Do I Need FDA Approval, Clearance, or Exemption? Medical Device Guide

Most Class I devices and some Class II devices are exempt from 510(k), but only within the limits set in their classification regulation. To check yours, find your device's product code in FDA's Product Classification database, then read its classification regulation and the limitations of exemption for its device panel.

Key takeaways

• We measured FDA's classification file: 2,155 of 2,403 Class I product codes (89.7%) and 484 of 3,644 Class II codes (13.3%) are 510(k)-exempt.
• Class I does not always mean exempt. 156 Class I product codes still need a 510(k), including patient examination gloves.
• An exempt device still needs a 510(k) if its intended use or its fundamental technology differs from legally marketed devices of its type.
• Exempt devices still need registration, listing, labeling and adverse event reporting. Only 530 of the 2,155 exempt Class I codes are also exempt from manufacturing practice rules.
• Across all devices listed with FDA, 45.5% are in 510(k)-exempt product codes. For Korean establishments, the share is 37.8%.

Which devices are exempt from 510(k)?

Most Class I devices and some Class II devices [1]. Under the law, a 510(k) is not required for a device type classified into Class I, or for a device FDA has exempted under section 510(m) [4]. Class III devices are not exempt; they generally need premarket approval. Devices legally marketed before May 28, 1976, and not significantly changed since, may also not need a 510(k) [1].

Some Class I devices are reserved. The Class I exemption does not cover a device intended for a use of substantial importance in preventing impairment of human health. It also does not cover one that presents a potential unreasonable risk of illness or injury [4].

We analyzed all 7,094 product codes in FDA's classification file. In 2026, the file dated September 21 shows [3]:

Class	Product codes	510(k)-exempt	Still need a 510(k)
Class I	2,403	2,155 (89.7%)	156
Class II	3,644	484 (13.3%)	3,004
Class III	527	0	Premarket approval route

Some Class I and Class II product codes fall under FDA enforcement discretion or other categories instead, so the columns do not add up to the totals [3].

The exempt list keeps changing. Under the 21st Century Cures Act, FDA exempted 66 Class I and 336 Class II product codes in 2017, and codified them in a final order on December 30, 2019. Smaller groups followed [1]. The most recent FDA lists, on June 18, 2025, exempted clinical electronic thermometers [1]. Check the current database, not an old list.

Does Class I always mean exempt?

No. 156 Class I product codes still require a 510(k) [3]. They include reprocessed tracheobronchial suction catheters and 30 clinical chemistry test systems [3].

Patient examination gloves are the classic example. We checked the regulation text: they are Class I under 21 CFR 880.6250 [6]. The same regulation exempts only finger cots from 510(k), so an examination glove needs a 510(k) [6]. The class alone would have given the wrong answer; the regulation text gives the right one.

Our FDA device classification guide explains how classes are assigned.

How do you check whether your device is exempt?

Follow these steps, in order:

1. Find your product code. Search FDA's Product Classification database by device name or keyword, and pick the product code whose definition matches your device [2].
2. Read the submission type. The database shows whether the product code needs a 510(k), is 510(k)-exempt, or needs premarket approval [2].
3. Read the classification regulation. Open the regulation number in the entry. An exempt device's regulation says it is exempt "subject to the limitations" in a section ending in .9, such as 878.9 [6, 10].
4. Check the limitations. The exemption covers your device only if it matches the existing or reasonably foreseeable characteristics of devices of that type [5]. The next section explains when it does not.
5. Check the manufacturing practice exemption separately. Some exempt devices are also exempt from most quality system requirements, in some regulations only if they are not labeled as sterile [10]. Most exempt devices are not [3].
6. Ask FDA if you are unsure. A 513(g) request for classification information asks FDA for its view. The fee for fiscal year 2027 is $8,596, or $4,298 for a small business [8].

Complizen's free class and pathway finder gives a first view of your likely class and pathway. It shows whether your device type is likely exempt, before you check the regulation itself.

When does an exempt device still need a 510(k)?

When it goes beyond what devices of its type already do. The limitations sections for each device panel share the same text. They say you must still submit a 510(k) if [5]:

• The intended use is different. FDA's examples: a different medical purpose, or lay use of a device previously used only by health care professionals.
• The fundamental technology is different. FDA's examples: a surgical instrument that cuts tissue with a laser rather than a sharpened metal blade. Or an in vitro diagnostic that uses DNA probes rather than culture or immunoassay.
• It is an in vitro diagnostic whose misdiagnosis could be associated with high morbidity or mortality, as each limitations section defines.

A change that is consistent with a predetermined change control plan (PCCP) that FDA has already cleared also does not need a new 510(k) [4].

What must an exempt device still comply with?

Exempt from 510(k) does not mean exempt from FDA. FDA says an exempt device must still comply with other regulatory controls, unless its regulation expressly exempts it [1]:

Requirement	What it means for an exempt device
Establishment registration and device listing	Register your establishment, list the device, and renew registration every year [11]. The fiscal year 2027 registration fee is $13,785 [8].
US agent	A foreign establishment must name a US agent as part of its registration [11].
Labeling	Required labeling rules in 21 CFR Part 801 apply, including English for required content [12].
Unique device identification (UDI)	Required, with exceptions. One covers Class I devices exempt from manufacturing practice rules [7].
Adverse event reporting	Medical device reporting under 21 CFR Part 803 applies.
Quality management system	The QMSR in 21 CFR Part 820 applies, unless the regulation exempts the device [1].

Manufacturing practice exemptions are narrower than the word "exempt" suggests. Only 530 of the 2,155 exempt Class I product codes (24.6%) are also exempt from manufacturing practice rules. No exempt Class II code is [3]. Where the exemption applies, some regulations limit it to devices not labeled or represented as sterile. It also keeps the requirements for records and complaint files under 21 CFR 820.35 [10].

Our registration and listing guide and our first-sale checklist cover these steps. The checklist is written for cleared devices, but its registration, listing, labeling and UDI steps apply to exempt devices too.

How common is the exempt route?

Common. We analyzed 262,401 device listings, matching each to its product code's 510(k) status and its establishment's country [3, 9]:

Establishments in	Device listings	In 510(k)-exempt product codes
South Korea	5,704	2,156 (37.8%)
Taiwan	5,167	2,785 (53.9%)
Japan	4,051	1,210 (29.9%)
India	6,095	3,553 (58.3%)
Malaysia	3,056	666 (21.8%)
Turkey	1,185	396 (33.4%)
United States	128,630	45,564 (35.4%)
All countries	262,401	119,462 (45.5%)

Source: our analysis of FDA's registration, listing and product classification files, dated September 21, 2026 [3, 9].

How we counted. We linked each listing to its establishment's country through FDA's registration file, and to its product code's 510(k) status through the classification file. A listing counts as exempt when all its product codes are 510(k)-exempt. A listing tied to establishments in more than one country counts once in each country's row, and once in the total.

Malaysia's lower share reflects gloves. 1,192 of its 3,056 listings (39.0%) are in glove product codes, against 1.3% or less for the other markets we checked. And 11 of FDA's 13 glove product codes need a 510(k) [3, 6, 9].

What should manufacturers outside the US do first?

If your device is exempt, you can sell it in the US without a 510(k). Our International Track covers registration, the US agent and importing. First, register your establishment, list your device and name your US agent. Your labeling and quality system must also meet FDA's rules [1, 11]. If only some of your devices are exempt, you can enter in phases: list the exempt devices first, and file 510(k)s for the others.

• Confirm each device separately. Exemption is decided product code by product code, and by the limitations in each regulation [5].
• Name a US agent. Our FDA US agent guide explains the role.
• Label in English. Required label content must be in English [12].

Complizen handles establishment registration and device listing for manufacturers entering the US.

Frequently asked questions

Which devices are exempt from 510(k)?

Most Class I devices and some Class II devices, as listed product code by product code in FDA's Product Classification database. We counted 2,155 exempt Class I product codes and 484 exempt Class II codes. No Class III device is exempt from premarket review.

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

No. 156 Class I product codes still need a 510(k), including patient examination gloves. Class I devices intended for a use of substantial importance in preventing impairment of health are not covered by the exemption. Neither are those that present a potential unreasonable risk.

How do I know if my device is 510(k) exempt?

Search FDA's Product Classification database for your device's product code and check its submission type. Then read the classification regulation it cites, and the limitations section ending in .9 for that device panel, to confirm your device fits the exemption.

Can an exempt device still need a 510(k)?

Yes. You must submit a 510(k) if your device has a different intended use, such as lay use of a professional device. The same applies if it uses a different fundamental technology than legally marketed devices of its type. Some in vitro diagnostics also need one, under each panel's limitations.

Do exempt devices need FDA registration?

Yes. An exempt device's establishment must register with FDA, list its devices and renew its registration every year. The establishment registration fee for fiscal year 2027 is $13,785. A foreign establishment must also name a US agent as part of its registration.

Do exempt devices need to follow the QMSR?

Usually. FDA says every device is subject to the quality system rules unless its regulation exempts it. Only 530 of 2,155 exempt Class I product codes are exempt from manufacturing practice rules, and they keep the requirements for records and complaint files.

Do exempt devices need a UDI?

Most do. The UDI labeling rule has an exception for Class I devices that FDA has exempted from manufacturing practice rules. Other exempt devices generally must carry a UDI on their label and packaging, and submit data to FDA's GUDID database, unless another exception applies.

What does "subject to the limitations in .9" mean?

Each device panel in FDA's regulations has a section ending in .9, such as 878.9, that limits exemptions. An exemption covers only devices with the existing or reasonably foreseeable characteristics of their type, not new uses or new technologies. FDA's examples include lay use of a professional device, and a laser in place of a blade.

Can I ask FDA whether my device is exempt?

Yes. A 513(g) request for classification information asks FDA for its view on your device's classification and requirements. The fee for fiscal year 2027 is $8,596, or $4,298 for a qualified small business. Use it when the database and the regulation leave your device's status unclear, before you commit to a pathway.

Can FDA exempt more devices over time?

Yes. Since the 21st Century Cures Act, FDA has exempted hundreds of product codes, including 336 Class II codes in July 2017. The most recent change FDA lists, in June 2025, exempted clinical electronic thermometers. Always check the current database rather than an old list.

Are Class II devices ever exempt from 510(k)?

Yes. We counted 484 Class II product codes that are 510(k)-exempt, about 13% of Class II codes. None of them is also exempt from manufacturing practice rules, so the full quality management system requirements still apply. The latest Class II exemption FDA lists covers clinical electronic thermometers, in June 2025.

How many devices listed with FDA are 510(k) exempt?

In our analysis of FDA's files dated September 21, 2026, 45.5% of device listings were in 510(k)-exempt product codes. The share was 37.8% for Korean establishments, 53.9% for Taiwanese and 58.3% for Indian establishments. Malaysia's was the lowest in our table, at 21.8%, largely because 39% of its listings are gloves, and most glove types need a 510(k).

References

1. FDA. Class I and Class II Device Exemptions. Content current as of July 1, 2025.
2. FDA. Product Classification database. Accessed September 26, 2026.
3. FDA. Download Product Code Classification Files, classification file dated September 21, 2026.
4. US Code. 21 U.S.C. 360, including subsections (l) and (m). Accessed September 26, 2026.
5. eCFR. 21 CFR 878.9, Limitations of exemptions from section 510(k). Accessed September 26, 2026.
6. eCFR. 21 CFR 880.6250, Non-powdered patient examination glove. Accessed September 26, 2026.
7. eCFR. 21 CFR 801.30, General exceptions from the requirement for the label of a device to bear a UDI. Accessed September 26, 2026.
8. Federal Register. Medical Device User Fee Rates for Fiscal Year 2027, 91 FR 48134. Published July 30, 2026.
9. FDA. Establishment Registration and Medical Device Listing Files for Download, files dated September 21, 2026.
10. eCFR. 21 CFR 868.5420, Ether hook, an example of current manufacturing practice exemption wording. Accessed September 26, 2026.
11. eCFR. 21 CFR Part 807, Establishment Registration and Device Listing. Accessed September 26, 2026.
12. eCFR. 21 CFR 801.15, Medical devices; prominence of required label statements. Accessed September 26, 2026.