A Class II medical device needs special controls, such as performance standards or device-specific guidance, because FDA's general controls alone cannot assure its safety and effectiveness. Most Class II devices need a 510(k) before sale in the US, and 96% of the 510(k)s FDA cleared in 2025 were Class II.
Key takeaways
- We analyzed every 510(k) FDA cleared in 2025: 3,064 of 3,198 were Class II devices, across 710 product codes.
- FDA's classification file, dated October 5, 2026, lists 3,644 Class II product codes: 3,004 need a 510(k), and 484 are exempt.
- The most-cleared Class II device types in 2025 were automated radiological image processing software (94), powered laser surgical instruments (83) and radiological image processing systems (58).
- Traditional 510(k)s for Class II devices cleared in 2025 took a median of 142 calendar days from receipt to decision.
- Applicants based outside the US received 52% of Class II clearances in 2025, including 153 in South Korea, 86 in Japan and 63 in Taiwan.
What is a Class II medical device?
It is a device that needs more than FDA's general controls. The law places a device in Class II when general controls alone are not enough to give reasonable assurance of its safety and effectiveness. There must also be enough information to set special controls [1].
FDA's risk ranking follows the same order. Class I devices generally pose the lowest risk to patients and users, and Class III devices the highest [2]. Class II sits between them. Our device classification hub explains how FDA's product codes carry each class.
| Class I | Class II | Class III | |
|---|---|---|---|
| Product codes in FDA's file | 2,403 | 3,644 | 528 |
| Usual route to market | Exempt from 510(k) | 510(k) | Premarket approval (PMA) |
| 510(k)s cleared in 2025 | 70 | 3,064 | 0 |
Source: our analysis of FDA's classification file dated October 5, 2026, and openFDA records of 510(k) decisions in 2025 [4, 5]. The other 64 clearances in 2025 were for unclassified device types or could not be matched.
Our FDA device classification guide explains how FDA assigns all three classes.
What are examples of Class II medical devices?
Class II covers a wide range, from image processing software to dental implants. FDA cleared Class II devices in 710 different product codes in 2025 [5]. These types were cleared most often:
| Device type | Product code | 21 CFR | Cleared in 2025 |
|---|---|---|---|
| Automated radiological image processing software | QIH | 892.2050 | 94 |
| Powered laser surgical instrument | GEX | 878.4810 | 83 |
| Radiological image processing system | LLZ | 892.2050 | 58 |
| Pulsed Doppler ultrasound imaging system | IYN | 892.1550 | 57 |
| Bone fixation plate | HRS | 888.3030 | 54 |
| Electrosurgical cutting and coagulation device | GEI | 878.4400 | 52 |
| Over-the-counter light-based wrinkle reduction device | OHS | 878.4810 | 42 |
| Orthopedic stereotaxic instrument | OLO | 882.4560 | 40 |
| Dental implant abutment | NHA | 872.3630 | 40 |
| Root-form endosseous dental implant | DZE | 872.3640 | 31 |
| Powered wheelchair | ITI | 890.3860 | 29 |
| Lumbar intervertebral fusion device with bone graft | MAX | 888.3080 | 29 |
Source: our analysis of openFDA 510(k) decisions from January 1 to December 31, 2025, matched to FDA's classification file [4, 5].
By FDA review committee, radiology led with 478 Class II clearances in 2025. Orthopedics followed with 404, then general and plastic surgery with 377, and cardiovascular devices with 349 [5].
Laboratory tests are Class II too. About a third of Class II product codes, 1,165 of 3,644, sit in FDA's laboratory specialties: clinical chemistry, hematology, immunology, microbiology, pathology and toxicology [4].
So are some consumer products. 25 Class II product codes are named as over-the-counter devices, including pregnancy test kits, blood glucose test systems and hearing aids [4].
What are the requirements for a Class II device?
General controls plus special controls. General controls apply to every device unless its classification regulation exempts it [3]. They include:
- rules against adulterated and misbranded devices
- establishment registration, device listing and premarket notification (510(k))
- notification, repair, replacement, refund and recall duties
- records and reports, including adverse event reports and unique device identification
- good manufacturing practice requirements, which now sit in FDA's Quality Management System Regulation (QMSR) [3, 7]
Special controls are specific to the device type. FDA lists performance standards, postmarket surveillance, patient registries, special labeling, premarket data requirements and guidelines [3]. Each classification regulation states the controls for its device type [6]:
| Device type | 21 CFR | What the regulation says |
|---|---|---|
| Root-form endosseous dental implant | 872.3640 | Class II (special controls). A named FDA guidance document serves as the special control |
| Medical image management and processing system | 892.2050 | Class II (special controls), with voluntary standards: DICOM, JPEG and an SMPTE test pattern |
| Noninvasive blood pressure measurement system | 870.1130 | Class II (performance standards) |
| Powered wheelchair | 890.3860 | Class II (performance standards) |
| Metallic bone fixation appliances, such as bone plates | 888.3030 | Class II |
Source: eCFR, accessed October 9, 2026 [6].
One regulation can hold two classes. The laser surgical instrument regulation, 21 CFR 878.4810, is Class II. Its special laser gas mixtures are Class I and exempt from 510(k) [6].
Your product code leads to your regulation, and your regulation leads to your special controls. Complizen's classification tool returns your class and product code, every applicable special control with its 21 CFR citation, and the FDA guidance for your device type.
Does every Class II device need a 510(k)?
Most do, but not all. FDA's classification file, dated October 5, 2026, splits the 3,644 Class II product codes this way [4]:
| Route | Class II product codes | Share |
|---|---|---|
| 510(k) required | 3,004 | 82% |
| Exempt from 510(k) | 484 | 13% |
| Enforcement discretion | 155 | 4% |
One more code directs you to contact FDA. Of the 155 enforcement discretion codes, 152 are named as kits, trays or sets [4].
Exemptions have limits. An exemption covers only devices with the existing or reasonably foreseeable characteristics of their generic type, under the limitations in 21 CFR 862.9 to 892.9 [7]. FDA still adjusts them: its latest Class II action, dated October 6, 2026, covered 14 clinical toxicology test product codes [7].
Exempt from 510(k) does not mean exempt from the QMSR. None of the 484 exempt Class II product codes is also exempt from FDA's good manufacturing practice rules [4]. Our guide to 510(k) exempt devices shows how to check an exemption.
No predicate? A new type of device with low to moderate risk may be eligible for Class I or II through the De Novo process [2]. Once granted, it can serve as a predicate for later 510(k)s, unless it is exempt from 510(k) [8].
How does the 510(k) path work for a Class II device?
You show that your device is substantially equivalent to a legally marketed device, called a predicate [8]. The main steps:
- Confirm your product code and regulation. Together they set your special controls and whether you need a 510(k) [4, 6]. If you are unsure, a 513(g) request for classification information asks FDA for its view. For fiscal year 2027 it costs $8,596, or $4,298 for a small business [11].
- Choose a predicate. It can be a device cleared through a 510(k), one granted through De Novo, or one legally marketed before May 28, 1976 [8].
- Plan your testing. Test to the special controls and FDA's guidance for your device type [3, 6].
- Pay the user fee. For fiscal year 2027, the 510(k) fee is $28,653, or $7,163 for a qualified small business [11].
- Wait for FDA's decision. FDA's goal is a decision within 90 FDA days for 95% of 510(k)s [10].
- Receive a clearance order. FDA's order "clears" the device for commercial distribution [8].
General controls continue after clearance: registration, listing, reporting and the QMSR [3]. Our after-clearance checklist covers what to do before your first sale.
How long does a Class II 510(k) take?
Longer in calendar time than FDA's 90-day goal suggests. FDA's goal counts FDA days: calendar days when the submission is under review at FDA [10]. Time with you is tracked separately [10].
We measured calendar days from FDA's receipt to its decision for every Class II 510(k) cleared in 2025 [5]:
| 510(k) type | Class II clearances in 2025 | Median days | Middle half of cases |
|---|---|---|---|
| Traditional | 2,542 | 142 | 90 to 230 |
| Special | 466 | 30 | 27 to 57 |
| Abbreviated | 36 | 141 | 88 to 252 |
Source: our analysis of openFDA 510(k) decisions in 2025 [5]. Another 20 clearances used other review types.
More than a third took more than six months. 37% of Traditional 510(k)s for Class II devices took more than 180 days, and 2% more than a year [5].
Special 510(k)s were the fastest. FDA describes the Special 510(k) as an optional pathway for certain well-defined changes a manufacturer makes to its own legally marketed device [9].
What should manufacturers outside the US know?
FDA's Class II is not the EU's Class IIa or IIb. The EU divides devices into classes I, IIa, IIb and III under its own rules [12]. FDA sets your class through its own classification regulations and product codes [1, 4]. Check your FDA product code even if you hold a CE certificate.
Foreign manufacturers' clearances are almost all Class II. In 2025, 1,603 of the 1,672 clearances to applicants outside the US were Class II, about 96% [4, 5]. These applicants received 52% of all Class II clearances [5]. For manufacturers in these markets:
| Applicant country | All 510(k) clearances in 2025 | Class II |
|---|---|---|
| South Korea | 156 | 153 |
| Japan | 86 | 86 |
| Taiwan | 66 | 63 |
| India | 15 | 15 |
| Malaysia | 10 | 1 |
| Turkey | 5 | 5 |
Source: our analysis of openFDA 510(k) decisions in 2025, by the applicant's country [4, 5]. Applicants in the UAE and Saudi Arabia received no clearances in 2025.
Malaysia is the exception. 9 of its 10 clearances in 2025 were patient examination gloves, which are Class I [4, 5]. In South Korea, the most-cleared Class II types were electrosurgical devices (15) and laser surgical instruments (14) [5].
Not sure of your class? Complizen's free class and pathway finder gives a first view of your likely class and route, before you check the regulation itself.
Frequently asked questions
What is a Class II medical device?
A Class II medical device is one for which FDA's general controls alone are not enough to assure safety and effectiveness, so special controls also apply. Examples include powered wheelchairs, dental implants and radiology image processing software. Most Class II devices need a 510(k) before they can be sold in the US.
What are examples of Class II medical devices?
The Class II types FDA cleared most often in 2025 were automated radiological image processing software, powered laser surgical instruments and ultrasound imaging systems. Bone plates and electrosurgical devices followed. Class II also includes dental implants, powered wheelchairs, blood pressure monitors, many laboratory tests, and over-the-counter products such as pregnancy tests.
Do all Class II devices need a 510(k)?
No, but most do. Of the 3,644 Class II product codes in FDA's classification file, 3,004 need a 510(k) and 484 are exempt, within limits set in each regulation. Another 155, almost all kits, trays or sets, fall under FDA enforcement discretion. Check your own product code.
What are special controls?
Special controls are requirements for Class II devices that go beyond general controls. FDA lists performance standards, postmarket surveillance, patient registries, special labeling, premarket data requirements and guidelines. Each device type's classification regulation in 21 CFR states its own special controls, sometimes by naming an FDA guidance document.
What is the difference between Class I and Class II medical devices?
Class I devices need only general controls, and most are exempt from 510(k): 2,155 of 2,403 Class I product codes. Class II devices also need special controls, and most need a 510(k). FDA describes Class I devices as generally posing the lowest risk to patients and users.
What is the difference between Class II and Class III devices?
Class III devices generally pose the highest risk, and most need premarket approval (PMA): 497 of 528 Class III product codes. For fiscal year 2027, the standard PMA fee is $636,732, against $28,653 for a 510(k). A PMA device is approved, while a 510(k) device is cleared.
Is FDA Class II the same as EU Class IIa or IIb?
No. The EU uses classes I, IIa, IIb and III, set by its own rules under Regulation (EU) 2017/745. FDA assigns class through its own regulations and product codes. Your EU class does not tell you your FDA class, so check your FDA product code.
How long does FDA take to clear a Class II device?
FDA's goal is a decision within 90 FDA days for 95% of 510(k)s, but FDA days exclude time with you. In 2025, Traditional 510(k)s for Class II devices took a median of 142 calendar days from receipt to decision, and Special 510(k)s took 30.
How much does a Class II 510(k) cost in FDA fees?
For fiscal year 2027, which runs from October 1, 2026 to September 30, 2027, the FDA fee for a 510(k) is $28,653. A qualified small business pays $7,163. Testing and preparing the submission are separate costs on top of the fee.
Do Class II devices need to follow the QMSR?
Yes. Good manufacturing practice requirements are part of the general controls, and FDA now sets them in the QMSR. Only 6 of the 3,644 Class II product codes are exempt from these rules, and none of the 484 codes exempt from 510(k) is among them.
Can a Class II device be sold over the counter?
Yes. FDA's classification file names 25 Class II product codes as over-the-counter devices, including pregnancy test kits, blood glucose test systems and hearing aids. In 2025, FDA cleared 42 over-the-counter light-based wrinkle reduction devices, which are Class II. Check the product code: it shows whether your device needs a 510(k).
How do I find out if my device is Class II?
Search FDA's Product Classification database by device name and find the product code whose definition matches your device. The entry shows the class, regulation number and whether a 510(k) is needed. If you are unsure, a 513(g) request asks FDA for its view.
References
- Legal Information Institute, Cornell Law School. 21 U.S.C. 360c(a)(1)(B), Class II, special controls; and eCFR, 21 CFR 860.3, Definitions. Accessed October 9, 2026.
- FDA. Overview of Medical Device Classification and Reclassification. Content current as of December 19, 2017.
- FDA. Regulatory Controls. Content current as of March 27, 2018.
- FDA. Product Classification database and product code classification files, file dated October 5, 2026.
- openFDA. Device 510(k) API, 510(k) decisions dated January 1 to December 31, 2025. Accessed October 9, 2026.
- eCFR. Classification regulations 21 CFR 872.3640, 892.2050, 870.1130, 890.3860, 888.3030 and 878.4810. Accessed October 9, 2026.
- FDA. Class I and Class II Device Exemptions. Content current as of October 6, 2026.
- FDA. Premarket Notification 510(k). Content current as of August 22, 2024.
- FDA. The Special 510(k) Program. Guidance issued September 13, 2019.
- FDA. MDUFA Performance Goals and Procedures, Fiscal Years 2023 Through 2027 (MDUFA V commitment letter).
- Federal Register. Medical Device User Fee Rates for Fiscal Year 2027, 91 FR 48134. Published July 30, 2026.
- EUR-Lex. Regulation (EU) 2017/745 on medical devices, Article 51. Accessed October 9, 2026.