FDA 510(k) clearances for medical devices
FDA 510(k) clearances for medical devices: which devices were cleared to market, the applicant, the decision date, product code, device class, regulation number and advisory committee, plus a clearance-per-year breakdown. Search by device name, applicant company or K-number. Pairs with the adverse-events and enforcement endpoints for full medtech diligence.
Answeringour last check, 2026-09-24
1 of 1checks answered this week
414 msmedian answer time
$0.02listed price per call
$0.02price it asked us
Paid test badge: not yet. The checks above are free: we call the tool without paying and read the payment request it sends back. The Verified badge needs paid calls whose answers match the promised output, and nobody can buy a badge.
Endpoint
GET https://x402-filings.datalayer.workers.dev/v1/fda/device-clearances
| Category | Code and developer |
|---|---|
| Provider host | x402-filings.datalayer.workers.dev |
| Networks | eip155:8453 |
| Payment schemes | exact |
| Self-reported calls, 30 days | 2 from 1 payers (the provider's figure, not ours) |
Our checks, last 30 days
| Day | Result | HTTP | Asked | Time |
|---|---|---|---|---|
| 2026-09-24 | valid payment request | 402 | $0.02 | 414 ms |
Example input (from the provider)
{
"method": "GET",
"queryParams": {
"applicant": "Medtronic",
"device": "catheter",
"from": "2024-01-01",
"kNumber": "K123456",
"limit": 25,
"to": "2026-08-24"
},
"type": "http"
}
Promised output schema (from the provider)
{
"$schema": "https://json-schema.org/draft/2020-12/schema",
"properties": {
"input": {
"additionalProperties": false,
"properties": {
"method": {
"enum": [
"GET"
],
"type": "string"
},
"queryParams": {
"properties": {
"applicant": {
"description": "Applicant company name.",
"examples": [
"Medtronic"
],
"type": "string"
},
"device": {
"description": "Device name to search.",
"examples": [
"catheter"
],
"type": "string"
},
"from": {
"description": "Decision on or after, ISO date.",
"examples": [
"2024-01-01"
],
"type": "string"
},
"kNumber": {
"description": "Exact 510(k) number, e.g. K123456.",
"examples": [
"K123456"
],
"type": "string"
},
"limit": {
"description": "Max clearances, 1-100. Default 25.",
"examples": [
25
],
"type": "integer"
},
"to": {
"description": "Decision on or before, ISO date.",
"examples": [
"2026-08-24"
],
"type": "string"
}
},
"type": "object"
},
"type": {
"const": "http",
"type": "string"
}
},
"required": [
"type",
"method"
],
"type": "object"
},
"output": {
"properties": {
"example": {
"type": "object"
},
"type": {
"type": "string"
}
},
"required": [
"type"
],
"type": "object"
}
},
"required": [
"input"
],
"type": "object"
}