FDA 510(k) clearances for medical devices: which devices were cleared to market, the appli
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.
20000 (raw units)
price
3
calls / 30d
2
unique payers
2026-08-30
updated
Provider
x402-filings.datalayer.workers.dev · discovered, not yet claimed by its owner
Payment (x402 accepts[])
[
{
"scheme": "exact",
"network": "eip155:8453",
"payTo": "0x917e635b83F0dd7e8172c55EC4EEbb28B734cA85",
"asset": "0x833589fCD6eDb6E08f4c7C32D4f71b54bdA02913",
"amount": "20000",
"maxTimeoutSeconds": 60
}
]Output schema
{
"bazaar": {
"info": {
"input": {
"method": "GET",
"queryParams": {
"applicant": "Medtronic",
"device": "catheter",
"from": "2024-01-01",
"kNumber": "K123456",
"limit": 25,
"to": "2026-08-24"
},
"type": "http"
},
"output": {
"example": {
"clearances": [
{
"applicant": "Example Medical Inc.",
"decision": "Substantially Equivalent",
"decisionDate": "2026-08-11",
"deviceClass": "2",
"deviceName": "Example Catheter",
"kNumber": "K260123",
"reviewedByThirdParty": false
}
],
"clearancesByYear": [
{
"count": 14,
"year": "2026"
},
{
"count": 11,
"year": "2025"
}
],
"count": 25,
"mostRecentDecision": "2026-08-11",
"query": {
"device": "catheter",
"limit": 25
},
"totalMatching": 41233
},
"type": "json"
}
},
"schema": {
"$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"
}
}
}Use it
curl
curl "https://x402-filings.datalayer.workers.dev/v1/fda/device-clearances" # -> 402 Payment Required, accepts[] lists how to pay # retry with a PAYMENT-SIGNATURE (or PAYMENT header) once paid
JavaScript
const res = await fetch("https://x402-filings.datalayer.workers.dev/v1/fda/device-clearances");
if (res.status === 402) {
const { accepts } = await res.json();
// pay one of accepts[] via an x402 client, then retry with the payment header
}Python
import httpx
res = httpx.get("https://x402-filings.datalayer.workers.dev/v1/fda/device-clearances")
if res.status_code == 402:
accepts = res.json()["accepts"]
# pay one of accepts[] via an x402 client, then retry with the payment headerMachine-readable
Everything on this page is also available as clean JSON at /resources/6077.json, and this resource appears in /discovery/resources and /discovery/search.