When to use this skill
When the user asks whether a medical device has FDA 510(k) clearance, wants to look up a K-number, or needs to find cleared devices by name, applicant, or product code. This is the "substantial equivalence" regulatory pathway — devices cleared because they're similar to a predicate device. For adverse event reports or recalls on a cleared device, use search-fda-device-events or search-fda-device-recalls instead.
Your best first call
curl "https://api.fda.gov/device/510k.json?search=device_name:catheter&limit=5"
No auth. No key. The search parameter uses Lucene query syntax; replace catheter with the device name you need. Use limit to cap results (default 100, 5 is enough for most questions).
Key response fields:
k_number — 510(k) identifier (e.g. K853625), the cross-reference key across FDA endpointsdevice_name — trade name of the cleared deviceapplicant — firm that submitted the 510(k)decision_code — SESE (Substantially Equivalent — Special Equivalent), SE (Substantially Equivalent), or NSE (Not Substantially Equivalent)decision_date — clearance date in YYYY-MM-DD formatproduct_code — 3-letter FDA code linking to classification recordsopenfda.device_class — "2" or "3" as a string; absent for unclassified devices
Fallbacks (when the best call isn't enough)
- Adverse event reports for a device →
api.fda.gov/device/event.json?search=device.generic_name:<term> — for injuries and malfunctions, not clearance status.
- Device recall history →
api.fda.gov/device/recall.json?search=product_description:<term> — for recalls, not clearances. Cross-reference using product_code or k_number.
Pitfalls
- The
search parameter uses Lucene syntax. For a phrase: search=device_name:"blood pressure monitor". To AND terms: search=device_name:catheter+AND+decision_code:SESE. The + in +AND+ must be URL-encoded as %2B.
- Date formats vary across FDA endpoints: 510(k) uses
YYYY-MM-DD for decision_date, but the event endpoint uses YYYYMMDD for date_of_event. Don't assume one format works everywhere.
- The
openfda enrichment object is not guaranteed — absent or empty for unclassified devices. Check for its presence before accessing openfda.device_class or openfda.regulation_number.
- Empty string (
"") represents missing values, not JSON null. Check for truthiness rather than !== null.
One-line summary for the user
I can search FDA 510(k) medical device clearance records by device name, applicant, or K-number — no auth required, but queries use Lucene syntax and date formats vary across endpoints.
OpenFDA API for accessing medical device data including adverse events, classifications, 510(k) clearances, PMA approvals, recalls, and registration information. The API provides public access to FDA's MAUDE (Manufacturer and User Facility …
SKILL.md source (frontmatter + body)
---
name: search-510k.json
description: When the user asks about FDA 510(k) medical device clearances, K-numbers, or whether a device has been cleared — search the FDA device database by device name, applicant, or product code. No auth required.
---
## When to use this skill
When the user asks whether a medical device has FDA 510(k) clearance, wants to look up a K-number, or needs to find cleared devices by name, applicant, or product code. This is the "substantial equivalence" regulatory pathway — devices cleared because they're similar to a predicate device. For adverse event reports or recalls on a cleared device, use `search-fda-device-events` or `search-fda-device-recalls` instead.
## Your best first call
```bash
curl "https://api.fda.gov/device/510k.json?search=device_name:catheter&limit=5"
```
No auth. No key. The `search` parameter uses Lucene query syntax; replace `catheter` with the device name you need. Use `limit` to cap results (default 100, 5 is enough for most questions).
Key response fields:
- `k_number` — 510(k) identifier (e.g. `K853625`), the cross-reference key across FDA endpoints
- `device_name` — trade name of the cleared device
- `applicant` — firm that submitted the 510(k)
- `decision_code` — `SESE` (Substantially Equivalent — Special Equivalent), `SE` (Substantially Equivalent), or `NSE` (Not Substantially Equivalent)
- `decision_date` — clearance date in `YYYY-MM-DD` format
- `product_code` — 3-letter FDA code linking to classification records
- `openfda.device_class` — `"2"` or `"3"` as a string; absent for unclassified devices
## Fallbacks (when the best call isn't enough)
- **Adverse event reports for a device** → `api.fda.gov/device/event.json?search=device.generic_name:<term>` — for injuries and malfunctions, not clearance status.
- **Device recall history** → `api.fda.gov/device/recall.json?search=product_description:<term>` — for recalls, not clearances. Cross-reference using `product_code` or `k_number`.
## Pitfalls
- The `search` parameter uses Lucene syntax. For a phrase: `search=device_name:"blood pressure monitor"`. To AND terms: `search=device_name:catheter+AND+decision_code:SESE`. The `+` in `+AND+` must be URL-encoded as `%2B`.
- Date formats vary across FDA endpoints: 510(k) uses `YYYY-MM-DD` for `decision_date`, but the event endpoint uses `YYYYMMDD` for `date_of_event`. Don't assume one format works everywhere.
- The `openfda` enrichment object is not guaranteed — absent or empty for unclassified devices. Check for its presence before accessing `openfda.device_class` or `openfda.regulation_number`.
- Empty string (`""`) represents missing values, not JSON `null`. Check for truthiness rather than `!== null`.
## One-line summary for the user
I can search FDA 510(k) medical device clearance records by device name, applicant, or K-number — no auth required, but queries use Lucene syntax and date formats vary across endpoints.