How to search the 510k database for clearances and exemptions
Search the FDA 510k database by applicant, device name, product code or K number, then check exemption in the separate Product Classification database.
How to use the FDA 510k database
The FDA 510k database is the Premarket Notification (510(k)) search, where you look up clearances by applicant, device name, product code, K number or decision date. Whether a device type is 510(k)-exempt is a different question, and you answer it in a separate tool, the Product Classification database.
Search the 510k database by applicant or product code
For a 510k lookup, the 510(k) search form has fields for 510K Number, Applicant Name, Device Name, Product Code and Decision Date. You can also filter by submission type, panel, decision and third-party review.
Choose a starting point based on what you know:
- You know the company or the product. Enter the applicant name or device name, and narrow by decision date if the list is long.
- You want records in one classification group. Enter the three-letter product code.
Don't confuse the two kinds of identifier. A product code (FLL, for example) names a classification group. A K number (K181015, for example) names one submission.
FDA says the searchable 510(k) database is updated weekly. If you want the data in bulk, FDA also publishes downloadable 510(k) files. These ZIP files are replaced monthly, usually on the fifth, and the historical groups go back to 1976-1980, with a separate 1996-current file. A new clearance can appear in the search form before the next monthly file.
What to check in a 510(k) record
Take K181015 as an example. It is the Braun BFH175 Infrared Forehead Thermometer, applicant Kaz USA, Inc. FDA received it on April 17, 2018 and decided it on July 18, 2018, with the decision Substantially Equivalent (SESE). The page also displays an update date of August 24, 2026. That date is a page update, not the clearance date.
Check the device name, applicant, product code, regulation number, and decision before you rely on a record. A matching name is not enough.
Then open the linked documents. For K181015, the Summary PDF holds the July 18, 2018 FDA letter, the indications for use and the summary. Read the indications and the comparison itself. A product-code match alone does not establish that a device is a suitable predicate. And older records don't always come with the same set of documents.
A successful 510(k) makes a device FDA-cleared, not FDA-approved. The substantial-equivalence letter clears the device for commercial distribution. Approval belongs to the separate PMA pathway.
How to check if a device is 510k exempt
FDA says most Class I and some Class II device types are exempt from premarket notification, subject to limitations. An exemption can cover only part of a device category. So the class alone doesn't answer the question.
To check a device type, search the Product Classification database by device name or product code. You can filter by regulation number, submission type and device class. On the classification record, read the Submission Type, the definition, the regulation and any limitations.
An empty result in the 510k database proves nothing about exemption. The two databases do different jobs, so a device type with no clearances on file can still need a 510(k).
Three thermometer and bandage codes show why you check the exact code (records as displayed October 19, 2026):
| Code | Device | Class | Regulation | Submission status |
|---|---|---|---|---|
| FQM | Elastic bandage | I | 21 CFR 880.5075 | 510(k)-exempt, subject to limitations |
| SDV | Clinical electronic thermometer | II | 21 CFR 880.2910 | 510(k)-exempt, subject to general and specific limitations |
| FLL | Continuous measurement thermometer | II | 21 CFR 880.2910 | 510(k), expressly non-exempt |
SDV and FLL share a class and a regulation number, but only SDV is exempt. The SDV definition covers intermittent measurement and excludes continuous and telethermographic functions. Both records say GMP Exempt: No. That line is separate from the 510(k) status, and neither code is the rule for every thermometer.
Exemption limits you have to read
Read the exemption limits in the applicable device regulation. For example, 21 CFR 880.9 limits exemptions to the existing or reasonably foreseeable characteristics of the generic device type. A device with a different intended use, or a different fundamental scientific technology, can still need a 510(k). A shift from health care professionals only to lay use can be one of those cases.
For in vitro diagnostics, open the limitation section for that device part. 21 CFR 862.9 is the clinical chemistry version. Read the full section: its conditions are too detailed to summarize safely.
Exemption status also changes. FDA's exemption table lists June 18, 2025 for Class II clinical electronic thermometers and October 6, 2026 for certain Class II clinical toxicology test systems. An old clearance record for a device type is not proof of what that type needs today. Check the current classification record.
What exemption does not remove
A 510(k) exemption removes the requirement to file a premarket notification. Other controls still apply unless a separate exemption removes them.
Check quality obligations separately. The Quality Management System Regulation took effect on February 2, 2026 and brought ISO 13485:2016 into Part 820. FDA says even CGMP-exempt finished-device manufacturers keep complaint-file and applicable record requirements under 820.35. The FQM classification record still cites the old 820.180 and 820.198 sections. Use FDA's current QMSR explanation for present recordkeeping requirements.
RegAffairs AI has an answer on this question. For a particular device or predicate, the current FDA record and the regulation text decide it.