The gazetteer of regulatory clearances.
Verified FDA filings for biohacking devices, sourced from the public openFDA 510(k) and PMA endpoints. Every entry links to the device record on accessdata.fda.gov so you can confirm the source.
§ Data sourced from openFDA and refreshed by scripts/populate-fda-clearances.mjs. We do not host FDA data ourselves — every record links to the canonical entry on accessdata.fda.gov for verification.
Understanding FDA status.
What does FDA 510(k) clearance mean?
A 510(k) clearance means the FDA agreed a device is "substantially equivalent" to a legally marketed predicate device. It is a clearance, not an approval — the manufacturer demonstrated equivalence rather than proving safety and effectiveness through new clinical trials.
What is the difference between FDA "cleared" and FDA "approved"?
FDA "cleared" almost always refers to the 510(k) pathway (substantial equivalence). FDA "approved" refers to Premarket Approval (PMA), the stricter pathway requiring clinical evidence of safety and effectiveness for higher-risk (Class III) devices. Most biohacking wearables are cleared or registered, not approved.
What does "FDA registered" mean for a device?
FDA establishment registration and device listing mean the manufacturer told the FDA it makes the device. It is not a review, clearance, or endorsement of safety or effectiveness — "FDA registered" is the weakest regulatory signal and is often overstated in marketing.
Are general wellness devices FDA cleared?
No. Devices marketed under the FDA general wellness policy make only low-risk, general well-being claims and are not reviewed or cleared by the FDA. They may not claim to diagnose, treat, cure, or prevent any disease.
How can I verify a device's FDA clearance myself?
Every entry in this database links to the canonical record on accessdata.fda.gov via its K-number or PMA number. Search the FDA 510(k) or PMA database with that number to confirm the clearance independently.