{"openapi":"3.1.0","info":{"title":"Open FDA Devices (BYOK) API","version":"0.1.0","description":"Open FDA Devices (BYOK) lets an AI assistant read your own Open FDA Devices data through the Open FDA Devices API with a key you supply (openFDA API key). Read-only: 6 tools (search_device_510k_clearances, search_device_pma_approvals, search_device_classifications, search_device_udi, search_device_establishment_listings, count_device_records). The BYOK key travels with each request, is used for...\n\nEvery operation is read-only or compute-only. The same tools are available over MCP (streamable HTTP) at https://byok-openfda-devices.connectorbay.com/mcp.","contact":{"name":"Unify Dynamics LLC","email":"agent@connectorbay.com","url":"https://connectorbay.com/byok-openfda-devices/docs"},"termsOfService":"https://connectorbay.com/byok-openfda-devices/terms"},"servers":[{"url":"https://byok-openfda-devices.connectorbay.com"}],"externalDocs":{"url":"https://connectorbay.com/byok-openfda-devices/docs"},"security":[{"upstreamKey":[]}],"components":{"securitySchemes":{"bearer":{"type":"http","scheme":"bearer","description":"Optional. A Pro API key raises rate limits; no credentials are required."},"upstreamKey":{"type":"apiKey","in":"header","name":"X-Upstream-Key","description":"Your own key for the service this connector wraps (bring your own key). Used for that one call only; never stored, logged or cached."}},"schemas":{"Error":{"type":"object","properties":{"ok":{"const":false},"error":{"type":"object"}}}}},"paths":{"/v1/tools/search_device_510k_clearances":{"post":{"operationId":"search_device_510k_clearances","summary":"Search FDA 510(k) premarket notifications: K number, device name, applicant, decision and dates, product code, advisory ","description":"Search FDA 510(k) premarket notifications: K number, device name, applicant, decision and dates, product code, advisory committee, clearance type and summary type. Use for \"Which 510(k) clearances were decided for insulin pumps in 2025\".","tags":["tools"],"requestBody":{"required":true,"content":{"application/json":{"schema":{"properties":{"search":{"anyOf":[{"maxLength":500,"type":"string"},{"type":"null"}],"default":null,"description":"Search expression field:term, for example device_name:\"insulin pump\" AND decision_date:[20250101 TO 20251231]. Combine with AND / OR (written with spaces), put quotes around phrases, and use ranges like decision_date:[20240101 TO 20241231] on date fields (YYYYMMDD).","title":"Search"},"sort":{"anyOf":[{"maxLength":80,"type":"string"},{"type":"null"}],"default":null,"description":"Sort expression field:asc or field:desc, for example decision_date:desc.","title":"Sort"},"limit":{"anyOf":[{"maximum":100,"minimum":1,"type":"integer"},{"type":"null"}],"default":10,"description":"Records to return, 1 to 100.","title":"Limit"},"skip":{"anyOf":[{"maximum":25000,"minimum":0,"type":"integer"},{"type":"null"}],"default":0,"description":"Number of matching records to skip, 0 to 25000; use with limit to page.","title":"Skip"}},"title":"search_device_510k_clearancesArguments","type":"object"}}}},"responses":{"200":{"description":"Tool result. `ok: true` on success; `ok: false` with a structured `error` (provider_unavailable, upstream_error, bad_input) when the tool could not answer.","content":{"application/json":{"schema":{"type":"object","additionalProperties":true}}}},"422":{"description":"Arguments failed validation","content":{"application/json":{"schema":{"$ref":"#/components/schemas/Error"}}}},"429":{"description":"Rate limit exceeded (see Retry-After)","content":{"application/json":{"schema":{"$ref":"#/components/schemas/Error"}}}}},"x-read-only":true}},"/v1/tools/search_device_pma_approvals":{"post":{"operationId":"search_device_pma_approvals","summary":"Search FDA premarket approvals (PMA) and supplements: PMA number, supplement, trade and generic name, applicant, decisio","description":"Search FDA premarket approvals (PMA) and supplements: PMA number, supplement, trade and generic name, applicant, decision, dates, product code and advisory committee. Use for \"Which PMA approvals exist for cochlear implants\".","tags":["tools"],"requestBody":{"required":true,"content":{"application/json":{"schema":{"properties":{"search":{"anyOf":[{"maxLength":500,"type":"string"},{"type":"null"}],"default":null,"description":"Search expression field:term, for example generic_name:\"cochlear implant\". Combine with AND / OR (written with spaces), put quotes around phrases, and use ranges like decision_date:[20240101 TO 20241231] on date fields (YYYYMMDD).","title":"Search"},"sort":{"anyOf":[{"maxLength":80,"type":"string"},{"type":"null"}],"default":null,"description":"Sort expression field:asc or field:desc, for example decision_date:desc.","title":"Sort"},"limit":{"anyOf":[{"maximum":100,"minimum":1,"type":"integer"},{"type":"null"}],"default":10,"description":"Records to return, 1 to 100.","title":"Limit"},"skip":{"anyOf":[{"maximum":25000,"minimum":0,"type":"integer"},{"type":"null"}],"default":0,"description":"Number of matching records to skip, 0 to 25000; use with limit to page.","title":"Skip"}},"title":"search_device_pma_approvalsArguments","type":"object"}}}},"responses":{"200":{"description":"Tool result. `ok: true` on success; `ok: false` with a structured `error` (provider_unavailable, upstream_error, bad_input) when the tool could not answer.","content":{"application/json":{"schema":{"type":"object","additionalProperties":true}}}},"422":{"description":"Arguments failed validation","content":{"application/json":{"schema":{"$ref":"#/components/schemas/Error"}}}},"429":{"description":"Rate limit exceeded (see Retry-After)","content":{"application/json":{"schema":{"$ref":"#/components/schemas/Error"}}}}},"x-read-only":true}},"/v1/tools/search_device_classifications":{"post":{"operationId":"search_device_classifications","summary":"Search FDA device classifications by product code: device name, class (1, 2 or 3), regulation number, medical specialty,","description":"Search FDA device classifications by product code: device name, class (1, 2 or 3), regulation number, medical specialty, review panel and flags such as implant or life-sustaining. Use for \"What class is a daily-wear contact lens\".","tags":["tools"],"requestBody":{"required":true,"content":{"application/json":{"schema":{"properties":{"search":{"anyOf":[{"maxLength":500,"type":"string"},{"type":"null"}],"default":null,"description":"Search expression field:term, for example device_name:\"contact lens\". Combine with AND / OR (written with spaces), put quotes around phrases, and use ranges like decision_date:[20240101 TO 20241231] on date fields (YYYYMMDD).","title":"Search"},"sort":{"anyOf":[{"maxLength":80,"type":"string"},{"type":"null"}],"default":null,"description":"Sort expression field:asc or field:desc, for example device_name:asc.","title":"Sort"},"limit":{"anyOf":[{"maximum":100,"minimum":1,"type":"integer"},{"type":"null"}],"default":5,"description":"Records to return, 1 to 100.","title":"Limit"},"skip":{"anyOf":[{"maximum":25000,"minimum":0,"type":"integer"},{"type":"null"}],"default":0,"description":"Number of matching records to skip, 0 to 25000; use with limit to page.","title":"Skip"}},"title":"search_device_classificationsArguments","type":"object"}}}},"responses":{"200":{"description":"Tool result. `ok: true` on success; `ok: false` with a structured `error` (provider_unavailable, upstream_error, bad_input) when the tool could not answer.","content":{"application/json":{"schema":{"type":"object","additionalProperties":true}}}},"422":{"description":"Arguments failed validation","content":{"application/json":{"schema":{"$ref":"#/components/schemas/Error"}}}},"429":{"description":"Rate limit exceeded (see Retry-After)","content":{"application/json":{"schema":{"$ref":"#/components/schemas/Error"}}}}},"x-read-only":true}},"/v1/tools/search_device_udi":{"post":{"operationId":"search_device_udi","summary":"Search the Global UDI database of device identifiers: brand, company, model and catalog number, description, distributio","description":"Search the Global UDI database of device identifiers: brand, company, model and catalog number, description, distribution status, prescription flags, MRI safety, sterilization and product codes. Use for \"Find UDI records for the brand 'Accu-Chek'\".","tags":["tools"],"requestBody":{"required":true,"content":{"application/json":{"schema":{"properties":{"search":{"anyOf":[{"maxLength":500,"type":"string"},{"type":"null"}],"default":null,"description":"Search expression field:term, for example brand_name:\"Accu-Chek\". Combine with AND / OR (written with spaces), put quotes around phrases, and use ranges like decision_date:[20240101 TO 20241231] on date fields (YYYYMMDD).","title":"Search"},"sort":{"anyOf":[{"maxLength":80,"type":"string"},{"type":"null"}],"default":null,"description":"Sort expression field:asc or field:desc, for example public_version_date:desc.","title":"Sort"},"limit":{"anyOf":[{"maximum":100,"minimum":1,"type":"integer"},{"type":"null"}],"default":5,"description":"Records to return, 1 to 100.","title":"Limit"},"skip":{"anyOf":[{"maximum":25000,"minimum":0,"type":"integer"},{"type":"null"}],"default":0,"description":"Number of matching records to skip, 0 to 25000; use with limit to page.","title":"Skip"}},"title":"search_device_udiArguments","type":"object"}}}},"responses":{"200":{"description":"Tool result. `ok: true` on success; `ok: false` with a structured `error` (provider_unavailable, upstream_error, bad_input) when the tool could not answer.","content":{"application/json":{"schema":{"type":"object","additionalProperties":true}}}},"422":{"description":"Arguments failed validation","content":{"application/json":{"schema":{"$ref":"#/components/schemas/Error"}}}},"429":{"description":"Rate limit exceeded (see Retry-After)","content":{"application/json":{"schema":{"$ref":"#/components/schemas/Error"}}}}},"x-read-only":true}},"/v1/tools/search_device_establishment_listings":{"post":{"operationId":"search_device_establishment_listings","summary":"Search FDA device registration and listing records: proprietary names, establishment types, linked 510(k) and PMA number","description":"Search FDA device registration and listing records: proprietary names, establishment types, linked 510(k) and PMA numbers, listed products and registration details. Use for \"Which establishments list a product linked to 510(k) K123456\".","tags":["tools"],"requestBody":{"required":true,"content":{"application/json":{"schema":{"properties":{"search":{"anyOf":[{"maxLength":500,"type":"string"},{"type":"null"}],"default":null,"description":"Search expression field:term, for example k_number:K123456. Combine with AND / OR (written with spaces), put quotes around phrases, and use ranges like decision_date:[20240101 TO 20241231] on date fields (YYYYMMDD).","title":"Search"},"sort":{"anyOf":[{"maxLength":80,"type":"string"},{"type":"null"}],"default":null,"description":"Sort expression field:asc or field:desc.","title":"Sort"},"limit":{"anyOf":[{"maximum":100,"minimum":1,"type":"integer"},{"type":"null"}],"default":5,"description":"Records to return, 1 to 100.","title":"Limit"},"skip":{"anyOf":[{"maximum":25000,"minimum":0,"type":"integer"},{"type":"null"}],"default":0,"description":"Number of matching records to skip, 0 to 25000; use with limit to page.","title":"Skip"}},"title":"search_device_establishment_listingsArguments","type":"object"}}}},"responses":{"200":{"description":"Tool result. `ok: true` on success; `ok: false` with a structured `error` (provider_unavailable, upstream_error, bad_input) when the tool could not answer.","content":{"application/json":{"schema":{"type":"object","additionalProperties":true}}}},"422":{"description":"Arguments failed validation","content":{"application/json":{"schema":{"$ref":"#/components/schemas/Error"}}}},"429":{"description":"Rate limit exceeded (see Retry-After)","content":{"application/json":{"schema":{"$ref":"#/components/schemas/Error"}}}}},"x-read-only":true}},"/v1/tools/count_device_records":{"post":{"operationId":"count_device_records","summary":"Count how often each value of a field occurs among matching records of one device dataset, for example 510(k) decisions ","description":"Count how often each value of a field occurs among matching records of one device dataset, for example 510(k) decisions by decision_code. Returns term and count pairs. Use for \"How many 510(k) submissions got each decision code\".","tags":["tools"],"requestBody":{"required":true,"content":{"application/json":{"schema":{"properties":{"dataset":{"description":"Dataset to count in: 510k, pma, classification, udi or registrationlisting.","enum":["510k","pma","classification","udi","registrationlisting"],"title":"Dataset","type":"string"},"count":{"description":"Field to count, for example decision_code.exact for 510k, device_class.exact for classification (the .exact suffix counts whole values).","maxLength":120,"title":"Count","type":"string"},"search":{"anyOf":[{"maxLength":500,"type":"string"},{"type":"null"}],"default":null,"description":"Optional search expression restricting which records are counted, for example decision_date:[20250101 TO 20251231].","title":"Search"},"limit":{"anyOf":[{"maximum":1000,"minimum":1,"type":"integer"},{"type":"null"}],"default":25,"description":"How many distinct values to return, 1 to 1000 (most frequent first).","title":"Limit"}},"required":["dataset","count"],"title":"count_device_recordsArguments","type":"object"}}}},"responses":{"200":{"description":"Tool result. `ok: true` on success; `ok: false` with a structured `error` (provider_unavailable, upstream_error, bad_input) when the tool could not answer.","content":{"application/json":{"schema":{"type":"object","additionalProperties":true}}}},"422":{"description":"Arguments failed validation","content":{"application/json":{"schema":{"$ref":"#/components/schemas/Error"}}}},"429":{"description":"Rate limit exceeded (see Retry-After)","content":{"application/json":{"schema":{"$ref":"#/components/schemas/Error"}}}}},"x-read-only":true}}}}