Search 510(k) clearances search_510k_clearances
Use when the user wants predicate devices, a competitor's clearances, or the 510(k) history of a product code, company or device type.
Documentation
MedTech by 10xAnd gives an AI assistant 20 read-only tools over public FDA data and a budgetary cost model for prototype parts. This page says how to connect it, what each tool does, and where its limits are.
Server address: https://10xand.com/mcp. No account, API key or sign-in is needed. Choose “no authentication” when the assistant asks.
All 20 tools are read-only: none writes, orders, uploads, emails or stores anything. Tools marked live FDA query openFDA when called; the rest use data or a cost model that ships with the server.
Use when the user wants predicate devices, a competitor's clearances, or the 510(k) history of a product code, company or device type.
Use when the user asks what class a device is, which regulation covers it, whether it is 510(k) exempt, or what a product code means.
Use when the user asks what goes wrong with a type of device, about complaint or failure trends, about MAUDE reports for a product code, or whether a device is safe. Report counts are not rates and cannot establish whether a device is safe.
Use when the user pastes a UDI or barcode string and wants the device identifier, lot, serial or dates, or wants to know if it is valid.
Use when the user asks which consensus standards apply to a device, product code or regulation, or whether FDA recognizes a standard.
Use when the user asks what kinds of parts or processes can be quoted, or before quoting if the process is unclear.
Use when the user describes a part in words and the process, material or quantity needs pinning down before a quote.
Use when the user asks what a prototype or small batch of a part would cost or how long it would take.
Use when the user asks which material to use for a part or how a material choice changes cost.
Use when the user wants a shop, contract manufacturer or supplier for a part or process, near a location or overseas.
Use when the user wants more about one supplier from a find_suppliers result.
Use when the user asks about shipping options or what 10xAnd charges to source a part.
Use first for MAUDE questions about the product codes it covers, including whether such a device is safe. It separates duplicate reports from distinct events; report counts are not rates and cannot establish whether a device is safe.
Use when the user attaches a drawing, CAD export or part photo and asks for a price, cost or lead time.
Use when the user shares a BOM, parts list or assembly and wants it costed or sourced line by line.
Use when the user names a device brand or manufacturer and asks about its adverse-event reports, without knowing the product code.
Use when the user asks how to sterilize a device, compares EtO, gamma, e-beam, steam or VHP, or asks which sterilization validation standard applies.
Use when the user asks how long to age packaging or a device in a chamber to support a shelf-life claim, or about ASTM F1980, Q10 or pull schedules.
Use when the user describes a device idea and asks what it takes to bring it to market: FDA pathway, class, timeline, budget or test plan.
Use when the user wants a product demo video or animation of a device moving through anatomy, or asks how to show where a catheter, scope or implant goes.
The server keeps no account and stores nothing you send. It does not log the text of requests. A drawing attached in ChatGPT is read by the assistant, which passes only the fields it read; the file itself is never fetched by this server. Details are in the privacy policy and the terms.
List the tools yourself:
curl -s https://10xand.com/mcp \
-H "content-type: application/json" \
-H "accept: application/json, text/event-stream" \
-d '{"jsonrpc":"2.0","id":1,"method":"tools/list"}' Questions or problems: [email protected] or the support page. Please do not email confidential drawings.