openfda_devices.clearance.premarket_510k
shallowio.github.whiteknightonhorse/apibase · Verify this server
Search FDA 510(k) premarket clearance submissions — 175,000+ cleared medical devices. Returns k_number, device name, applicant, decision (SESE=cleared), decision date, product code, advisory committee specialty, and clearance type (Traditional/Special/Abbreviated). Filter by device name, k-number, applicant, or product code. A 510(k) clearance means FDA determined the device is substantially equivalent to a legally marketed predicate device. Useful for market research, competitive analysis, and regulatory pathway planning. Source: FDA CDRH 510(k) database, US public domain.
1 trials · measured 26 days ago
openfda_devices.clearance.premarket_510k scores 100.0/100 on Vouch's measured behaviour index, from 1 real invocation trials against io.github.whiteknightonhorse/apibase, measured 23 Sept 2026 under methodology v0.2.0. Every measured component scored 100.
Component breakdown
| Component | Weight | Value |
|---|---|---|
| Reliability | 35% | not applicable |
| Schema integrity | 25% | 100.0 |
| Failure behaviour | 15% | not applicable |
| Latency | 15% | not applicable |
| Concurrency | 10% | not applicable |
Tool details
- Transport
- remote + stdio
- Credential class
- self-provisionable
- Input schema
- not declared
- Output schema
- not declared
- Side-effect classification
- unclassified
Score history
| Day | Score | Tier | Methodology |
|---|---|---|---|
| 2026-09-23 | 100.0 | shallow | v0.2.0 |
Probe evidence
| Probe | Outcomes |
|---|---|
| schema_integrity | pass: 1 |
Raw request/response logs are not archived yet — the outcome counts above are drawn directly from every recorded trial.
Embed this score
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[](https://vouch.tools/tools/559a3aed-a0fc-4738-82ae-3da5d5bafdfc)