FDA sorts medical devices into Class I, II or III, from lowest to highest risk, and the class sets the controls a device needs. Your product code sets the class: most Class I codes are exempt from 510(k), most Class II codes need a 510(k), and most Class III codes need Premarket Approval (PMA).

Key takeaways

  • FDA's classification data lists 7,095 product codes: 2,403 in Class I, 3,644 in Class II and 528 in Class III, as of October 12, 2026.
  • About 90% of Class I codes (2,155) are exempt from 510(k). But 156 still need one, including every patient examination glove code.
  • 82% of Class II codes (3,004) need a 510(k). 497 of the 528 Class III codes are limited to a PMA.
  • Implants are not always Class III. 407 Class II product codes are implants, including root-form dental implants.
  • If you cannot tell your class, a 513(g) request gets FDA's written view within 60 days. It costs $8,596, or $4,298 for a small business, from October 1, 2026.

What are the three FDA medical device classes?

FDA has three device classes, and each one adds controls. The class depends on your device's intended use, its indications for use and the risk it poses. FDA says Class I includes the devices with the lowest risk, and Class III those with the greatest risk [1].

FDA's rules define each class by the controls it needs, in 21 CFR 860.3 [5]:

  • Class I: general controls are enough to give reasonable assurance of safety and effectiveness.
  • Class II: general controls alone are not enough, but special controls can close the gap. Special controls include performance standards, postmarket surveillance, patient registries and FDA guidance.
  • Class III: general and special controls are not enough. The device also supports or sustains life, is of substantial importance in preventing impairment of health, or presents a potential unreasonable risk of illness or injury. These devices need premarket approval.

General controls apply to every class. They include the rules against adulteration and misbranding, establishment registration, device listing, records and reports, and good manufacturing practice [5].

FDA has classified about 1,700 generic device types and grouped them into 16 medical specialty panels [1]. Each type has a classification regulation in 21 CFR Parts 862 to 892, and one or more three-letter product codes. Our device classification reference page explains how a product code carries its class.

  Class I Class II Class III
Risk, as FDA ranks it Lowest Middle Greatest
Controls General controls General and special controls General controls and PMA
Product codes 2,403 3,644 528
Usual route to market Exempt from 510(k): 2,155 codes 510(k): 3,004 codes PMA: 497 codes

Source: our count of FDA's product classification data via openFDA, exported October 12, 2026 [4]. Another 520 product codes are not classified (383), unclassified (86) or Humanitarian Device Exemption devices (51).

What are examples of Class I, II and III devices?

Bandages are Class I and pacemakers are Class III. The detail that matters is the product code, because the code tells you the route to market. Every example below comes from FDA's classification data [4].

Device Product code 21 CFR Class Route to market
Elastic bandage FQM 880.5075 I Exempt from 510(k)
Tongue depressor (non-surgical) FMA 880.6230 I Exempt from 510(k)
Manual stethoscope LDE 870.1875 I Exempt from 510(k)
Scalpel blade GES 878.4800 I Exempt from 510(k)
Polymer patient examination glove, such as nitrile LZA 880.6250 I 510(k)
Surgeon's glove KGO 878.4460 I 510(k)
Clinical mercury thermometer FLK 880.2920 II Exempt from 510(k)
Powered wheelchair ITI 890.3860 II 510(k)
Over-the-counter pregnancy test LCX 862.1155 II 510(k)
Non-invasive blood pressure system DXN 870.1130 II 510(k)
Infusion pump FRN 880.5725 II 510(k)
Root-form dental implant DZE 872.3640 II 510(k)
Implantable pacemaker pulse generator DXY 870.3610 III PMA
Silicone gel-filled breast implant FTR 878.3540 III PMA
Intraocular lens HQL 886.3600 III PMA

Source: FDA product classification data via openFDA, exported October 12, 2026 [4].

Three patterns in this table catch manufacturers out:

  • Class I can still need a 510(k). Exam gloves and surgeon's gloves are Class I, and both need clearance.
  • Class II can be exempt. FDA's own example, the clinical mercury thermometer, is Class II [1]. Its regulation exempts it from 510(k) [5].
  • Implants are not always Class III. 407 Class II product codes are implants, including root-form dental implants [4].

For more Class II examples, see our guide to Class II medical devices and the 510(k) path.

What share of medical devices is in each class?

It depends on what you count, and FDA publishes different figures. By product code, 34% of codes are Class I, 51% are Class II and 7% are Class III [4].

Source Class I Class II Class III What it counts
FDA consumer page, last updated December 29, 2017 [3] 47% 43% 10% Medical devices
FDA classification data, October 12, 2026 [4] 34% 51% 7% Product codes

The remaining 7% of product codes are unclassified, not classified or Humanitarian Device Exemption devices [4].

Exemption figures differ in the same way. FDA's consumer page says 95% of Class I devices are exempt from the regulatory process [3]. FDA's classification page says about 572 Class I device types, or 74%, are exempt from premarket notification [1]. By product code, 2,155 of 2,403 Class I codes are exempt, about 90% [4].

All three point the same way. Most Class I devices skip premarket review, and Class III is a small minority. For your own device, only one number matters: what your product code says.

Is every Class I device exempt from 510(k)?

No. 156 Class I product codes still require a 510(k), and every patient examination glove code is one of them [4].

All six patient examination glove codes fall under 21 CFR 880.6250, and all six require a 510(k). So does the surgeon's glove code, KGO, under 21 CFR 878.4460 [4, 5].

Exemptions have limits. An exemption covers only devices with the existing or reasonably foreseeable characteristics of their generic type. If your device meets a condition in its limitations section, 21 CFR 862.9 to 892.9, you must still submit a 510(k) [2]. Our guide on how to check whether your device is exempt walks through it.

Exempt does not mean unregulated. An exempt device must still meet the other regulatory controls, unless its regulation expressly exempts it [2]. These include establishment registration, device listing, labeling rules and adverse event reports. The annual establishment registration fee is $13,785 from October 1, 2026 [7].

Exempt from 510(k) is not exempt from the quality system rule. Only 532 of the 2,403 Class I product codes are exempt from FDA's good manufacturing practice requirements [4]. Even those keep some duties. The elastic bandage regulation, for example, still applies the records and complaint file requirements in 21 CFR 820.35 [5]. Part 820 has been the Quality Management System Regulation (QMSR) since February 2, 2026 [5].

What is the difference between Class I and Class II devices?

Class II devices need special controls on top of general controls, and most need a 510(k) before sale. Most Class I devices need neither [4, 5].

  Class I Class II
Controls General controls General and special controls
Product codes 2,403 3,644
Codes that need a 510(k) 156 (6%) 3,004 (82%)
Codes exempt from 510(k) 2,155 (90%) 484 (13%)
Codes exempt from good manufacturing practice rules 532 6
Codes eligible for Third Party Review 140 1,427 (39%)
Implant codes 3 407
Examples Elastic bandage, manual stethoscope, exam glove Powered wheelchair, pregnancy test, dental implant

Source: our count of FDA's product classification data, exported October 12, 2026 [4].

Third Party Review lets an FDA-accredited reviewer assess your 510(k). FDA must then decide within 30 days of the reviewer's recommendation [6].

Does every Class III device need a PMA?

Almost. 497 of the 528 Class III product codes are limited to a PMA, and none is limited to a 510(k) [4]. Of the rest, 27 codes direct you to contact FDA, and 4 are limited to a Humanitarian Device Exemption.

FDA approves a PMA. It clears a 510(k) and grants a De Novo request.

New devices start in Class III by law. Under section 513(f)(1) of the FD&C Act, a device not marketed before May 28, 1976 is automatically Class III [6]. The main exception is a device FDA finds substantially equivalent to an existing device type. A novel device can ask FDA for Class I or II through a De Novo request. This works if general or special controls can assure its safety and effectiveness [6]. Our De Novo guide covers the process.

A few older Class III types can still use a 510(k). FDA says a preamendments device, or one substantially equivalent to it, uses a 510(k) until FDA calls for PMAs for that type [1]. Check your product code entry for the current route.

How do you find your device's class?

Start from your intended use, then find the product code that matches it. That code gives you the class, the regulation and the submission type [1].

  1. Write down your intended use and indications for use. Class follows use, not only design. FDA's example is a scalpel: its intended use is to cut tissue, and "for making incisions in the cornea" is a narrower indication [1].
  2. Search FDA's Product Classification database by device name or keyword [4]. If you know your specialty, you can browse that panel's part of 21 CFR instead.
  3. Open the closest product code. Note its class, regulation number and submission type.
  4. Read the regulation, including its limitations section. An exemption applies only within those limits [2].
  5. Check recent clearances under the same code. They show how FDA treats devices like yours. Complizen's Knowledge module puts FDA's clearance, recall and adverse event records in one place for this step.

FDA's 16 panels map to these parts of 21 CFR [1]:

21 CFR Part Panel 21 CFR Part Panel
862 Chemistry and Toxicology 878 General and Plastic Surgery
864 Hematology and Pathology 880 General Hospital
866 Immunology and Microbiology 882 Neurology
868 Anesthesiology 884 Obstetrical and Gynecological
870 Cardiovascular 886 Ophthalmic
872 Dental 888 Orthopedic
874 Ear, Nose and Throat 890 Physical Medicine
876 Gastroenterology and Urology 892 Radiology

How do you read a product code entry?

Each entry answers the questions that shape your plan. Here are two real entries from FDA's data [4].

Field Nitrile exam glove (LZA) Dental implant (DZE) What it tells you
Regulation 21 CFR 880.6250 21 CFR 872.3640 Where the rules for the device type live
Class I II The level of control
Submission type 510(k) 510(k) Your route to market
GMP exempt No No Whether the quality system rule applies in full
Third Party Review Eligible Not eligible Whether an accredited reviewer can assess your 510(k)
Implant No Yes Whether the device stays in the body for 30 days or more

The glove is Class I, yet it needs a 510(k) and a full quality system. It can use Third Party Review. The dental implant is Class II and not eligible, so its 510(k) goes straight to FDA [4]. FDA treats a device as an implant if it is meant to stay in the body for 30 days or more [5].

Once you have a product code, the free pathway finder shows which route to market fits your device.

What if no product code fits your device?

Ask FDA directly with a 513(g) request, or request a new classification through De Novo. Use a Pre-Submission for testing questions, not for the class question [9].

A 513(g) request asks FDA which class and requirements apply to your device. The FD&C Act requires a written answer within 60 days [6]. FDA accepts 513(g) requests through the voluntary eSTAR template [9]. The fee is $8,596, or $4,298 for a small business, from October 1, 2026 [7].

The answer is useful but limited. FDA bases it only on the information you send. It is not a classification decision or final agency action, and it will not tell you which tests you need [9].

A Pre-Submission (Q-Sub) is the route for testing and evidence questions. FDA's 513(g) guidance points sponsors there for testing needs [9, 10]. FDA's goal is written feedback within 70 days of receipt, or 5 days before a meeting, whichever comes sooner [8]. Our Q-Submission page explains how to ask.

A De Novo request asks FDA to classify a novel device into Class I or II. It fits when no predicate exists, but general or special controls can still assure safety and effectiveness [6]. The fee is $191,020, or $47,755 for a small business, from October 1, 2026 [7].

Is your device sitting between two product codes? Complizen's Superagent has a workflow for classifying an ambiguous device. Its answers are cited to FDA records. Check its suggestion against the database entry before you rely on it.

If your device was on the US market before May 28, 1976, see how to prove preamendment status.

What does your class mean for FDA review time and fees?

Your class sets your route to market, and each route has its own FDA fee and review goal. The goals come from FDA's MDUFA V commitment letter, which covers fiscal years 2023 to 2027 [8].

Route Who uses it FDA fee from October 1, 2026 (standard / small business) FDA review goal
510(k) exempt Most Class I, some Class II No submission fee No premarket review
510(k) Most Class II, some Class I $28,653 / $7,163 Decision within 90 FDA days for 95% of submissions
De Novo Novel devices that general or special controls can cover $191,020 / $47,755 Decision within 150 FDA days for at least 70% of requests
PMA Most Class III $636,732 / $159,183 Decision within 180 FDA days for 90% of original PMAs without advisory committee input

Source: Federal Register, 91 FR 48134 [7], and the MDUFA V commitment letter [8].

FDA days are not calendar days. They count only the days your submission is under review at FDA [8]. Time spent waiting for your answers does not count, so real elapsed time runs longer. Device establishments also pay the $13,785 annual registration fee [7]. Every current rate is on our FDA user fees page.

Is FDA changing how any devices are classified?

Yes. FDA keeps adjusting exemptions, and it is reviewing which accessories could move into Class I on their own.

On October 6, 2026, FDA published a Federal Register notice, 91 FR 63478. It covers exempting 14 Class II clinical toxicology test product codes from 510(k) [2]. Check your product code again before each new submission.

FDA also asked for comments on a proposed list of accessories that may suit distinct classification in Class I. Comments were due by October 16, 2026, under Docket No. FDA-2025-N-6224 [11]. The process comes from section 513(f)(6) of the FD&C Act, added in 2017 [11]. FDA says the final action will not add any Class I devices to the design control requirements [11]. If you make accessories, watch for FDA's final list.

What do international manufacturers get wrong about FDA classes?

The most common mistake is assuming your home-country class carries over. It does not. FDA sets your class through its own product codes.

The EU, for example, sorts devices into four risk classes: I, IIa, IIb and III. The class comes from the rules in Annex VIII of the EU Medical Device Regulation [12]. FDA instead matches your device to a generic type it has already classified [1]. Your EU class does not tell you your FDA class. Our guide on what transfers from a CE mark to a 510(k) covers the EU side. For Korean manufacturers, see whether an MFDS licence helps with FDA clearance.

A low class does not mean no 510(k). We tested this against FDA's 510(k) data for Malaysia [4]. From January 1, 2023 to October 1, 2026, applicants in Malaysia received 59 clearances. 51 were gloves: 44 patient examination gloves and 7 surgeon's gloves. All 51 were Class I devices that still needed a 510(k). Our guide on whether an MDA registration helps with FDA clearance covers what transfers from Malaysia.

Plan testing around the FDA product code, not your home file. The code leads to the regulation and any special controls. Those decide what evidence FDA expects to see.

How are software and AI-enabled devices classified?

The same way as hardware: through a product code. In 2025, FDA cleared 94 510(k)s under product code QIH, automated radiological image processing software [4]. QIH is a Class II code under 21 CFR 892.2050, and it was the most-cleared Class II code that year [4]. Our analysis of FDA's AI-enabled device list shows where AI devices cluster.

Frequently asked questions

What are the three FDA medical device classes?

FDA uses Class I, Class II and Class III, from lowest to highest risk. Class I needs general controls, Class II adds special controls, and Class III usually needs Premarket Approval. FDA's data lists 2,403, 3,644 and 528 product codes in each class.

What is an example of a Class I medical device?

Elastic bandages, tongue depressors and manual stethoscopes are Class I devices, and all three are exempt from 510(k). Patient examination gloves are Class I too, but every exam glove product code still needs a 510(k). Always check the product code, not only the class.

What are examples of Class III medical devices?

Implantable pacemakers, silicone gel-filled breast implants and intraocular lenses are Class III, and all need Premarket Approval. In FDA's data, 497 of the 528 Class III product codes are limited to a PMA. Not every implant is Class III, though: root-form dental implants are Class II.

Are all Class I devices exempt from 510(k)?

No. About 90% of Class I product codes, 2,155 of 2,403, are exempt, but 156 still require a 510(k). Even an exempt device must stay within its regulation's limitations section, 21 CFR 862.9 to 892.9, or the exemption does not apply.

What is the difference between Class I and Class II medical devices?

Class II devices need special controls on top of general controls, and most need a 510(k). In FDA's data, 82% of Class II product codes need a 510(k), against 6% of Class I codes. Class II covers devices such as powered wheelchairs, pregnancy tests and infusion pumps.

Do 510(k)-exempt devices still need registration and a quality system?

Usually, yes. Exempt devices must still meet general controls, including establishment registration and device listing, unless their regulation says otherwise. Only 532 of 2,403 Class I product codes are exempt from FDA's good manufacturing practice requirements. Registration costs $13,785 a year from October 1, 2026.

How do I find my device's product code?

Search FDA's Product Classification database by device name or keyword, then open the closest entry. Check that its intended use matches yours, because class follows intended use and indications for use. If several codes look close, compare their regulations and recent clearances before you choose.

What happens if no product code matches my device?

You can submit a 513(g) request, and FDA must answer in writing within 60 days. For a new device that general or special controls can cover, a De Novo request can create a Class I or II classification. A 513(g) answer is FDA's view, not a classification decision.

How long does a 513(g) request take, and what does it cost?

FDA must respond within 60 days of receiving the request. The fee is $8,596 from October 1, 2026, or $4,298 for a qualifying small business. The answer is based only on what you send, and it is not a classification decision or final agency action.

Does my CE mark or MFDS class carry over to FDA?

No. FDA assigns class through its own product codes, whatever your class is in the EU, Korea or elsewhere. The EU uses classes I, IIa, IIb and III under its own rules. Some of your test evidence may still help, but you must work out your FDA class separately.

Can FDA change a device's class or exemption?

Yes. FDA can reclassify device types and add exemptions under the FD&C Act. On October 6, 2026, it published a notice on exempting 14 Class II clinical toxicology test codes from 510(k). Check your product code again before each new submission, because the route can change.

Is software classified differently from hardware?

No. Software that FDA regulates as a device gets a product code, a class and a route to market like any other device. In 2025, the most-cleared Class II product code was QIH, automated radiological image processing software, with 94 clearances through 510(k).

References

  1. FDA. Classify Your Medical Device and Device Classification Panels. Both content current as of August 26, 2026.
  2. FDA. Class I and Class II Device Exemptions. Content current as of October 6, 2026.
  3. FDA. Learn if a Medical Device Has Been Cleared by FDA for Marketing. Content current as of December 29, 2017.
  4. FDA. Product Classification database, and openFDA device classification and 510(k) data, exported October 12, 2026.
  5. eCFR. 21 CFR 860.3, Definitions; classification regulations in 21 CFR Parts 862 to 892, including 880.5075, 880.6250, 878.4460 and 880.2920; and 21 CFR Part 820. Accessed October 14, 2026.
  6. Legal Information Institute, Cornell Law School. 21 U.S.C. 360c (FD&C Act section 513) and 21 U.S.C. 360m (section 523). Accessed October 14, 2026.
  7. Federal Register. Medical Device User Fee Rates for Fiscal Year 2027, 91 FR 48134. Published July 30, 2026.
  8. FDA. MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027 (MDUFA V commitment letter).
  9. FDA. FDA and Industry Procedures for Section 513(g) Requests for Information. Guidance issued August 2024.
  10. FDA. Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. Final guidance issued May 2025.
  11. FDA. CDRH Issues Proposed List of Accessories Suitable for Distinct Classification as Devices. Content current as of August 26, 2026.
  12. European Commission, UDI Helpdesk. Medical device classification. Published May 19, 2026.