{"uid":"cap_cDiltXhQ7HaN63Li_aHiI","slug":"fda-510-k-medical-device-clearance-lookup-cd5aebcf","name":"FDA 510(k) Medical Device Clearance Lookup","description":"Look up US medical device 510(k) clearances and their decisions, newest decision first.","url":"https://win.oneshotagent.com/v1/tools/lookup/product-device-clearances?utm_source=zero.xyz","method":"POST","headers":{},"bodySchema":{"type":"object","properties":{"limit":{"type":"integer","description":"The most clearance records to return. From 1 to 25. Defaults to `10`."},"k_number":{"type":"string","description":"The clearance number, for example K253582"},"applicant":{"type":"string","description":"The company that applied, matched as words. 2 to 100 characters."},"device_name":{"type":"string","description":"The device name, matched as words. 2 to 100 characters."},"product_code":{"type":"string","description":"The FDA product code"}}},"responseSchema":{"type":"json","example":{"total":12,"clearances":[{"city":"Cupertino","state":"CA","decision":"Substantially Equivalent","k_number":"K253582","applicant":"Apple, Inc.","device_name":"Medical Imaging Calibration Feature (MICF)","country_code":"US","device_class":"1","product_code":"SHN","summary_type":"Summary","decision_code":"SESE","decision_date":"2026-04-01","received_date":"2025-11-17","clearance_type":"Traditional","medical_specialty":"Radiology","regulation_number":"892.1940","third_party_review":false},{"city":null,"state":null,"decision":"Substantially Equivalent","k_number":"K250507","applicant":"Apple, Inc.","device_name":"Hypertension Notification Feature (HTNF)","country_code":null,"device_class":"2","product_code":"SFR","summary_type":null,"decision_code":"SESE","decision_date":"2025-09-11","received_date":"2025-02-21","clearance_type":"Traditional","medical_specialty":"Cardiovascular","regulation_number":"870.2380","third_party_review":null}]}},"example":null,"exampleRequest":null,"tags":["x402"],"displayCostAmount":"0.005","displayCostAsset":"USDC","priceDynamic":false,"priceHint":null,"priceStatus":"priced","priceSource":"probe","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":"$0.005/call","primary":{"kind":"static","protocol":"x402","network":"base","amountUsd":"0.005","per":"call","confidence":"exact"},"accepted":[{"kind":"static","protocol":"x402","network":"base","amountUsd":"0.005","per":"call","confidence":"exact"}]},"paymentMethods":[{"uid":"pm_-Mt_8Rb-szjqV_M6av-PZ","protocol":"x402","methodType":"crypto","chain":"base","mode":"charge","costAmount":"0.005","costPer":"request","priority":0,"asset":"0x833589fCD6eDb6E08f4c7C32D4f71b54bdA02913","unit":"request","depositMicros":null,"planRef":null}],"brandName":null,"brandSlug":null,"brandBaseUrl":null,"brandDocsUrl":null,"whatItDoes":"Look up US FDA 510(k) medical device clearances and their decisions, sorted newest first.","exampleAgentPrompt":"Can you look up the FDA 510(k) clearance records for Medtronic's glucose monitoring devices — show me the 5 most recent clearances?","exampleUseCases":[{"title":"Verify competitor device clearance status","prompt":"Look up the 10 most recent FDA 510(k) clearances granted to Abbott Laboratories for their cardiac devices — I want to see what they've gotten cleared recently."},{"title":"Retrieve clearance by K number","prompt":"Can you pull up the FDA 510(k) clearance record for K253582? I need the decision and device details."},{"title":"Research cleared devices by product code","prompt":"Find me the latest 15 FDA 510(k) clearances under product code FPA so I can see what similar devices have been approved."}],"resultDescription":"Returns a list of 510(k) clearance records sorted newest-first, each containing the K number, applicant name, device name, FDA product code, decision, and decision date — up to 25 records per call.","failureModes":["No records found for the given search criteria — returns empty result set","Invalid K number format — the k_number field must match the standard format (e.g. K253582)","applicant or device_name string too short (under 2 characters) or too long (over 100 characters) — validation error","limit out of range — must be between 1 and 25","Payment failure — x402 payment of $0.005 USDC not fulfilled"],"whenToPreferThis":"Use this endpoint when you need to look up official US FDA 510(k) clearance records for medical devices, whether searching by K number, company name, device name, or FDA product code. Prefer this over general web search when you need structured, authoritative clearance data directly from the FDA database. Best suited for regulatory research, competitive intelligence on cleared devices, and compliance verification workflows.","instructions":null,"reviewSummary":null,"reviewSummaryHighlights":null,"reviewSummaryConcerns":null,"reviewSummaryGeneratedAt":null,"activationCount":0,"lastUsedAt":null,"lastSuccessfullyRanAt":null,"lastHealthCheckAt":"2026-10-29T07:20:20.927Z","isFirstParty":false,"canonicalSlug":"fda-510-k-medical-device-clearance-lookup-cd5aebcf"}