openfda_devices.clearance.premarket_510k
Search FDA 510(k) premarket clearance submissions — 175,000+ cleared medical devices. Returns k_number, device name, applicant, decision (SESE=cleared), decision date, product code, advisory committee specialty, and clearance type (Traditional/Special/Abbreviated). Filter by device name, k-number...
This record as markdown: /tools/io-github-whiteknightonhorse-apibase/openfda-devices.clearance.premarket-510k.md
What openfda_devices.clearance.premarket_510k does on Apibase
AI agents call openfda_devices.clearance.premarket_510k to retrieve information from Apibase 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 |
|---|---|---|---|
skip | integer | — | Number of records to skip for pagination (default 0). |
limit | integer | — | Number of records to return (1–99, default 10). |
search | string | — | OpenFDA search expression using Lucene syntax. Single field: device_name:"pacemaker" or recall_status:"Ongoing". Combined: device_name:"insulin pump"+AND+recall |
Parameters from the server's own tool schema.
Why openfda_devices.clearance.premarket_510k is rated Low
Tool queries public FDA medical device clearance data without modification, creation, or deletion capabilities.
From the tool's definition Search FDA 510(k) premarket clearance submissions, public domain database, returns device information.
Attacks that exploit this kind of access
The rule that runs openfda_devices.clearance.premarket_510k safely
PolicyLayer is an MCP gateway: it sits between your AI agents and Apibase, and checks every tool call against a rule you set before the call runs. Nothing changes on the server itself. For openfda_devices.clearance.premarket_510k, this is the rule to start with:
openfda_devices.clearance.premarket_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 Apibase, apply this rule, and every openfda_devices.clearance.premarket_510k call is checked against it from then on.
Questions about openfda_devices.clearance.premarket_510k
Search FDA 510(k) premarket clearance submissions — 175,000+ cleared medical devices. Returns k_number, device name, applicant, decision (SESE=cleared), decision date, product code, advisory committee specialty, and clearance type (Traditional/Special/Abbreviated). Filter by device name, k-number, applicant, or product code. A 510(k) clearance means FDA determined the device is substantially equivalent to a legally marketed predicate device. Useful for market research, competitive analysis, and regulatory pathway planning. Source: FDA CDRH 510(k) database, US public domain. It is categorised as a Read tool in the Apibase MCP Server, which means it retrieves data without modifying state.
openfda_devices.clearance.premarket_510k accepts 3 parameters: skip, limit, search. The full parameter table on this page comes from the server's own tool schema.
Register the Apibase MCP server in PolicyLayer and add a rule for openfda_devices.clearance.premarket_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 Apibase. Nothing to install.
openfda_devices.clearance.premarket_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 openfda_devices.clearance.premarket_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 openfda_devices.clearance.premarket_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.
openfda_devices.clearance.premarket_510k is provided by the Apibase MCP server (apibase-mcp-client). PolicyLayer sits as a proxy in front of this server to enforce policies before tool calls reach the server.
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