510(k) Overview — What is a 510(k)?
The 510(k) is a uniquely American regulatory pathway. No other major medical device jurisdiction has an exact equivalent, though similarities exist with Australia's "comparable overseas regulator" pathway and Singapore's abridged route.
What is a 510(k)?
A 510(k) (pronounced "five-ten-kay") is a premarket submission made to FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed device (the "predicate device") that was on the market before May 28, 1976, or has been subsequently cleared by FDA through 510(k).
The name derives from Section 510(k) of the FD&C Act [21 U.S.C. § 360(k)], which requires certain manufacturers to notify FDA at least 90 days before marketing a device.
When is a 510(k) required?
A 510(k) is required before marketing a device that:
- Is not exempt from 510(k) requirements; and
- Is a Class II device, or a Class I device that FDA has determined requires 510(k) notification; or
- Introduces a change to a legally marketed device that could significantly affect safety or effectiveness.
A 510(k) is not required for:
- Devices that are Class I 510(k)-exempt (the majority of Class I devices)
- Devices approved under PMA (which follow the supplement pathway for changes)
- Investigational devices with valid IDE approval
Clearance vs approval — an important distinction
FDA clears a 510(k) — it does not "approve" it. This matters:
- Clearance = FDA has determined the device is substantially equivalent to a predicate → may be marketed
- Approval = used only for PMA devices — a higher standard requiring demonstration of safety and effectiveness through valid scientific evidence
Describing a 510(k)-cleared device as "FDA approved" is technically incorrect and can be a labelling violation.
Key features of the 510(k) pathway
| Feature | Detail |
|---|---|
| Standard review time (MDUFA VI) | 90 calendar days (Total Time to Decision) |
| Decision options | SE (cleared), NSE (not cleared), Withdrawal |
| Predicate | Must be legally marketed in the USA |
| Clinical data | Not always required — depends on device type and risk |
| Fees (FY2026) | ~$23,000 (small business rate available) |
| Database | 510(k) Database |
After 510(k) clearance
A cleared 510(k) authorises marketing. Post-clearance, the manufacturer must:
- Register the establishment and list the device
- Comply with QMS (QMSR), labelling, MDR, and UDI requirements
- Evaluate future changes to determine if a new 510(k) is required