{"uid":"cap_fjIl0etMPRgfXl_SB25Jt","slug":"fda-medical-device-classification-lookup-39b596ca","name":"FDA Medical Device Classification Lookup","description":"FDA medical device classification — the regulatory class and controls for a device type. Search by device name or FDA product code and get back the device class (I/II/III, mapping to regulatory risk and controls), CFR regulation number, medical specialty/review panel, the official definition, and flags for life-sustaining/supporting, implant, GMP-exempt, and third-party-review eligibility. Free, public-domain US government data. The authoritative answer to \"what FDA class is this device and what regulation governs it\" — for regulatory and medical-device diligence; point-in-time public records, not regulatory advice.","url":"https://2s.io/api/medical/device-classification","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)."},"productCode":{"type":"string","description":"FDA product code (3-letter)."}}}}}}},"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_VzySERrbJCaLIcPm9jlzx","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":"Looks up FDA medical device classifications by device name or product code, returning regulatory class, submission type, specialty, and safety flags.","exampleAgentPrompt":"Look up the FDA classification for 'catheter' — I need the device class, submission type, medical specialty, and whether it's a life-sustaining or implantable device. Return up to 5 results.","exampleUseCases":null,"resultDescription":"Returns an array of FDA device classification records, each including device name, class (I/II/III), 3-letter product code, review panel, submission type, medical specialty, CFR regulation number, and boolean flags for implant status, life-sustain/support, GMP exemption, and third-party review eligibility. Also includes total count of matching records and the data source (OpenFDA).","failureModes":["No results returned if device name or product code doesn't match any FDA record","Invalid product code format may return empty results","Limit parameter out of range (1-50) causes validation error","Ambiguous partial device name may return unrelated device types","OpenFDA upstream outage may cause 502/503 errors"],"whenToPreferThis":"Use this endpoint when you need authoritative FDA regulatory classification data for a medical device — specifically the device class, submission pathway, review panel, or safety flags (implant, life-sustaining). Prefer this over general web search when you need structured, machine-readable regulatory ground-truth for compliance, due diligence, or medical device research tasks.","instructions":null,"reviewSummary":null,"reviewSummaryHighlights":null,"reviewSummaryConcerns":null,"reviewSummaryGeneratedAt":null,"activationCount":0,"lastUsedAt":null,"lastSuccessfullyRanAt":null,"lastHealthCheckAt":"2026-09-14T06:44:42.639Z","isFirstParty":false}