{"uid":"cap_PTXb6SbZSHS-nrCkfIUu3","slug":"2s-fda-medical-device-510-k-clearance-lookup-a92ae07b","name":"2s FDA Medical Device 510(k) Clearance Lookup","description":"FDA 510(k) premarket clearances — the record of medical devices cleared for US marketing by demonstrating substantial equivalence to a predicate device. Search by device name, applicant (manufacturer), or FDA product code, and get back each clearance with its K-number, device name, applicant, decision date and decision description, clearance type (traditional/special/abbreviated), product code, advisory committee, and date received — newest decision first. Free, public-domain US government data. Authoritative regulatory-status data for medical-device diligence; point-in-time public records, not regulatory advice.","url":"https://2s.io/api/medical/device-510k","method":"GET","headers":{},"bodySchema":{"type":"object","$schema":"https://json-schema.org/draft/2020-12/schema","required":["input"],"properties":{"input":{"type":"object","required":["type","method","queryParams"],"properties":{"type":{"const":"http"},"method":{"const":"GET"},"queryParams":{"properties":{"limit":{"type":"integer","default":10,"maximum":50,"minimum":1},"device":{"type":"string","description":"Device name (partial)."},"applicant":{"type":"string","description":"Applicant / manufacturer name."},"productCode":{"type":"string","description":"FDA product code (3-letter, e.g. DXY)."}}}}}}},"responseSchema":null,"example":null,"exampleRequest":null,"tags":["x402"],"displayCostAmount":"0.0018","displayCostAsset":"USDC","priceDynamic":false,"priceHint":null,"priceStatus":"priced","priceSource":"settled","requiresHandshake":false,"reviewCount":0,"rating":{"score":"0.00","successRate":"0.00","reviews":0,"stars":null,"state":"unrated"},"availabilityStatus":"unknown","priceObserved":null,"sessionDeposit":null,"pricing":{"kind":"static","summary":"$0.0018/call","primary":{"kind":"static","protocol":"x402","network":"base","amountUsd":"0.0045","per":"call","confidence":"exact"},"accepted":[{"kind":"static","protocol":"x402","network":"base","amountUsd":"0.0045","per":"call","confidence":"exact"}]},"paymentMethods":[{"uid":"pm_HBEvVNlPOPIuZlmhR0AAJ","protocol":"x402","methodType":"crypto","chain":"base","mode":"charge","costAmount":"0.0045","costPer":"request","priority":0,"asset":"0x833589fCD6eDb6E08f4c7C32D4f71b54bdA02913","unit":"request","depositMicros":null,"planRef":null}],"brandName":null,"brandSlug":null,"brandBaseUrl":null,"brandDocsUrl":null,"whatItDoes":"Searches FDA 510(k) clearance records by device name, applicant/manufacturer, or product code, returning official clearance details including K-number, decision date, and advisory committee.","exampleAgentPrompt":"Can you search the FDA 510(k) clearance database for pacemaker devices made by Medtronic and show me up to 10 results, including their K-numbers and decision dates?","exampleUseCases":null,"resultDescription":"Returns a list of FDA 510(k) clearance records matching the query, each with K-number, applicant/manufacturer name, device name, FDA product code, date received, decision date, clearance type (e.g. Traditional), advisory committee (e.g. Cardiovascular), decision description (e.g. Substantially Equivalent), and state/country. Also includes total count of matching records and the data source attribution.","failureModes":["No matching records found for the given query parameters — returns empty clearances array with totalCount 0","Invalid product code format (not 3-letter) may return empty results or error","Limit parameter out of range (must be 1–50) returns validation error","Partial device name too vague may return unrelated results","OpenFDA upstream outage may cause failed or delayed responses"],"whenToPreferThis":"Use this endpoint when you need authoritative FDA 510(k) clearance data, including K-numbers, decision dates, and clearance type classifications. Prefer this over general web searches when you need structured, machine-readable regulatory records for medical devices. Ideal for compliance research, due diligence, competitive intelligence on medical device manufacturers, or verifying whether a specific device has received FDA clearance.","instructions":null,"reviewSummary":null,"reviewSummaryHighlights":null,"reviewSummaryConcerns":null,"reviewSummaryGeneratedAt":null,"activationCount":0,"lastUsedAt":null,"lastSuccessfullyRanAt":null,"lastHealthCheckAt":"2026-09-14T00:57:01.276Z","isFirstParty":false}