GET /510k.json
Summary: Search 510(k) premarket notifications
Operation ID: get510kNotifications
Auth: unknown
Operation ID: get510kNotifications
Auth: unknown
Description
Access the FDA's 510(k) premarket notification database containing submissions for devices that are substantially equivalent to legally marketed devices. These are cleared devices that do not require a full premarket approval (PMA) application.
Parameters (4)
count
(string, query, optional)
Field to count/aggregate results by
limit
(integer, query, optional, default: 1)
Maximum number of results to return (1-1000)
Constraints: {'minimum': 1, 'maximum': 1000}
search
(string, query, optional)
Search query using openFDA search syntax. Example: 'device_name:surgical' to search by device name.
skip
(integer, query, optional, default: 0)
Number of results to skip (for pagination)
Constraints: {'minimum': 0}
Examples (3)
| Title | Type | URL | Action |
|---|---|---|---|
| Search for pacemaker devices | curl |
https://api.fda.gov/device/510k.json?search=device_name:pacemaker&limit=5 |
|
| Search stent devices with pagination | curl |
https://api.fda.gov/device/510k.json?search=device_name:stent&limit=10&skip=0 |
|
| Count submissions by product code | curl |
https://api.fda.gov/device/510k.json?search=decision_code:SE&count=product_code&limit=100 |
Probe History
Status Codes
| Time | Status | Latency | Size |
|---|---|---|---|
| 2026-03-23 09:40:05.817333 | 200 | 932ms | |
| 2026-03-23 09:26:43.302412 | 200 | 867ms | |
| 2026-03-23 09:01:09.498629 | 404 | 885ms |
Response Changes
| When | Old | New |
|---|---|---|
| 2026-03-23 09:26:43.302412 | 57b1e7534d00 |
42de680c2247 |
| 2026-03-23 09:40:05.817333 | 42de680c2247 |
173e3b59f880 |