fda_device_510k
FDA 510(k) clearances for medical devices. The 510(k) pathway is how most non-high-risk devices come to market in the US. Filter by manufacturer (applicant), device name, product code, or decision date range. Used for competitive intel, device R&D scouting, M&A research.
This record as markdown: /tools/io-github-blackboxfoundry-livedatalink/fda-device-510k.md
What fda_device_510k does on Livedatalink
AI agents call fda_device_510k to retrieve information from Livedatalink without modifying anything. It is typically the context-gathering step in research, monitoring, and reporting workflows, before the agent takes action elsewhere.
| Parameter | Type | Required | Description |
|---|---|---|---|
limit | number | — | Maximum rows to return (default 25, max 100). |
query | string | — | Manufacturer (applicant) name or device name search term. |
end_date | string | — | Inclusive ISO date upper bound (YYYY-MM-DD). |
start_date | string | — | Inclusive ISO date lower bound (YYYY-MM-DD). |
product_code | string | — | Optional product code (e.g. 'DXJ' for ECG). |
Parameters from the server's own tool schema.
Why fda_device_510k is rated Low
This tool queries a public FDA database to retrieve historical medical device clearance information. It has no side effects, cannot modify records, execute commands, or affect financial systems. The blast radius of misuse is minimal—an agent could only retrieve existing public data about device clearances. No irreversible actions or external operations are triggered.
From the tool's definition Tool retrieves FDA 510(k) clearance data with filtering options (manufacturer, device name, product code, decision date); no modification, deletion, or execution capability described.
Attacks that exploit this kind of access
The rule that runs fda_device_510k safely
PolicyLayer is an MCP gateway: it sits between your AI agents and Livedatalink, and checks every tool call against a rule you set before the call runs. Nothing changes on the server itself. For fda_device_510k, this is the rule to start with:
fda_device_510k is read-only, so it stays allowed. Everything else on the server is denied unless you say otherwise.
The button opens the PolicyLayer dashboard: create your workspace, connect Livedatalink, apply this rule, and every fda_device_510k call is checked against it from then on.
Questions about fda_device_510k
FDA 510(k) clearances for medical devices. The 510(k) pathway is how most non-high-risk devices come to market in the US. Filter by manufacturer (applicant), device name, product code, or decision date range. Used for competitive intel, device R&D scouting, M&A research. It is categorised as a Read tool in the Livedatalink MCP Server, which means it retrieves data without modifying state.
fda_device_510k accepts 5 parameters: limit, query, end_date, start_date, product_code. The full parameter table on this page comes from the server's own tool schema.
Register the Livedatalink MCP server in PolicyLayer and add a rule for fda_device_510k: allow, deny, rate-limit, or require approval. Point your MCP client at the PolicyLayer proxy URL and the rule is enforced on every call, before it reaches Livedatalink. Nothing to install.
fda_device_510k is a Read tool with low risk. Read-only tools are generally safe to allow by default.
Yes. Add a rate_limit block to the fda_device_510k rule in your PolicyLayer policy. For example, setting max: 10 and window: 60 limits the tool to 10 calls per minute. Rate limits are tracked per agent session and reset automatically.
Set action: deny in the PolicyLayer policy for fda_device_510k. The AI agent will receive a policy violation error and cannot call the tool. You can also include a reason field to explain why the tool is blocked.
fda_device_510k is provided by the Livedatalink MCP server (https://livedatalink.ai/mcp). PolicyLayer sits as a proxy in front of this server to enforce policies before tool calls reach the server.
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