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Open FDA Devices (BYOK) — connector documentation

  • MCP endpoint: https://byok-openfda-devices.connectorbay.com/mcp
  • REST API: POST https://byok-openfda-devices.connectorbay.com/v1/tools/{tool_name}, described by the OpenAPI 3.1 spec at https://byok-openfda-devices.connectorbay.com/openapi.json
  • Transport: Streamable HTTP, stateless, MCP specification 2025-06-18 or later
  • Authentication: your own Open FDA Devices openFDA API key, sent in the X-Upstream-Key header of every request (never stored, logged or cached)
  • Health: https://byok-openfda-devices.connectorbay.com/health · Tool schemas: https://byok-openfda-devices.connectorbay.com/tools.json
  • Publisher: Unify Dynamics LLC · connectorbay.com/byok-openfda-devices · agent@connectorbay.com

What Open FDA Devices (BYOK) is for

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 that one call only and is never stored, logged or cached; it is only ever sent to api.fda.gov. Unofficial connector by Unify Dynamics LLC: not affiliated with, endorsed by or sponsored by Open FDA Devices. Open FDA Devices and its logos are trademarks of their owners and are used only to say which service the connector works with.

Ask your assistant things like:

  • "Which 510(k) clearances were decided for insulin pumps in 2025?"
  • "Which PMA approvals exist for cochlear implants?"
  • "What class is a daily-wear contact lens?"
  • "Find UDI records for the brand 'Accu-Chek'."
  • "Which establishments list a product linked to 510(k) K123456?"
  • "How many 510(k) submissions got each decision code?"

What it does

  • search_device_510k_clearances: Search FDA 510(k) premarket notifications: K number, device name, applicant, decision and dates, product code, advisory committee, clearance type and summary type.
  • search_device_pma_approvals: Search FDA premarket approvals (PMA) and supplements: PMA number, supplement, trade and generic name, applicant, decision, dates, product code and advisory committee.
  • search_device_classifications: 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.
  • search_device_udi: 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.
  • search_device_establishment_listings: Search FDA device registration and listing records: proprietary names, establishment types, linked 510(k) and PMA numbers, listed products and registration details.
  • count_device_records: 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.

BYOK key

You bring your own Open FDA Devices openFDA API key (https://open.fda.gov/apis/authentication/). Your assistant sends it in the X-Upstream-Key header with each request. ConnectorBay uses it for that one call only: it is never stored, logged or cached, never shown in an answer, and it is only sent to api.fda.gov over https, with no redirects followed. Create a key with the fewest permissions the tools need (read-only if the provider offers it), and revoke it at the provider whenever you like.

Notices

Data from openFDA (https://open.fda.gov). Credit is requested. openFDA does not validate the data, so do not use it for medical decisions.

Data sources

Live from the Open FDA Devices API (api.fda.gov) with a BYOK key; documentation: https://open.fda.gov/apis/device/. Endpoints checked against that documentation on 2026-10-16.

What it is not

Unofficial connector by Unify Dynamics LLC: not affiliated with, endorsed by or sponsored by Open FDA Devices. Open FDA Devices and its logos are trademarks of their owners and are used only to say which service the connector works with. It is read-only: it never creates, changes, sends or deletes anything in your Open FDA Devices account.

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