Quick Answer
FDA 510(k) is a premarket submission demonstrating that a medical device is substantially equivalent to a legally marketed device, allowing it to be cleared for the US market. For China-made devices, the manufacturer or a US agent submits the 510(k); buyers should verify clearance for the specific device in the FDA 510(k) database.
Understanding 510(k)
- Applies to many moderate-risk (Class II) devices
- Demonstrates substantial equivalence to a predicate device
- Results in FDA clearance (not 'approval') for the device
- Verify the specific device in the FDA 510(k) database
Some lower-risk devices are exempt and some higher-risk devices need PMA approval instead. Confirm the pathway for your device. See certification by country.
Key Takeaways
- 510(k) shows substantial equivalence to a predicate.
- Applies to many Class II devices.
- Results in FDA clearance, not approval.
- Verify the device in the FDA 510(k) database.
Frequently Asked Questions
What is FDA 510(k)?
510(k) is a premarket submission to the FDA demonstrating a device is substantially equivalent to a legally marketed (predicate) device, resulting in clearance to market it in the US.
Does a Chinese manufacturer hold the 510(k)?
The manufacturer (often via a US agent) submits and holds the 510(k). Buyers should verify that clearance exists for the specific device, not just that the manufacturer has other cleared products.
Is 510(k) clearance the same as FDA approval?
No. 510(k) results in 'clearance' based on substantial equivalence; 'approval' applies to higher-risk devices via the more rigorous PMA pathway.
How do I verify a 510(k)?
Search the FDA's public 510(k) database for the specific device and clearance number to confirm it is genuine and covers the exact product you are buying.
Can Plutonia verify FDA 510(k) clearance?
Yes. Plutonia verifies 510(k) clearances in the FDA database for the specific devices you are sourcing. Submit the product details to start.