UK Data for Agents

fda_device_510k_clearances

Read-onlyIdempotent

Finds US FDA 510(k) clearances by applicant (maker) and/or device name, newest decision first: K number, device, decision, clearance type, review time and device class. Answers "is this device FDA cleared?" and "what has this competitor had cleared recently?" for MedTech founders, regulatory consultants and investors. Source: FDA 510(k) premarket notification database via openFDA. Covers 510(k) only; high-risk Class III devices go through PMA (see fda_device_pma_approvals) and De Novo grants are not included. (cost: 1 credit)

Tool call template

This tool declares no required parameters. Add optional parameters from the input schema as needed.

{
  "id": 1,
  "jsonrpc": "2.0",
  "method": "tools/call",
  "params": {
    "arguments": {},
    "name": "fda_device_510k_clearances"
  }
}

Input Schema

Name	Required	Description
`limit`	No	integer, optional, 1-50, number of clearances to return, default 10
`device`	No	string, optional (applicant or device required), device name as submitted, e.g. "glucose monitor"
`applicant`	No	string, optional (applicant or device required), company that submitted the 510(k), e.g. "Dexcom"

Schema Changelog

Changes observed during successful MCP inspections.

AddedNov 5, 2026

TDQS

A4.4/5.0

Behavior4/5

Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?

Annotations already declare readOnly, idempotent, openWorld and non-destructive, so the safety profile is covered. The description adds genuinely useful context beyond that: result ordering (newest first), the source database (openFDA 510(k) premarket notifications), the scope boundary, and a 1-credit cost. It stops short of saying whether applicant/device matching is exact or fuzzy and how results are capped, which is the remaining behavioral gap.

Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.

Conciseness4/5

Is the description appropriately sized, front-loaded, and free of redundancy?

Front-loaded with purpose and result shape, then scope exclusions, then source and cost — a sound ordering with no wasted clauses. The audience list ("MedTech founders, regulatory consultants and investors") is mild filler that a routing agent does not strictly need.

Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.

Completeness5/5

Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?

There is no output schema, and the description compensates by enumerating the returned fields (K number, device, decision, clearance type, review time, device class) and the sort order. Combined with the coverage boundaries and cost note, an agent has everything needed to call it correctly and interpret the response.

Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.

Parameters3/5

Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?

Schema description coverage is 100%, including the 'applicant or device required' constraint and example values, so the baseline is 3. The description echoes the 'and/or' combining logic of applicant and device but adds no detail on match semantics (substring vs exact) or how the string-typed limit is parsed, so it does not exceed the schema.

Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.

Purpose5/5

Does the description clearly state what the tool does and how it differs from similar tools?

States a specific verb and resource ("Finds US FDA 510(k) clearances"), the two filter dimensions, the sort order (newest decision first), and the exact fields returned. A reader can distinguish it from fda_device_pma_approvals and fda_device_classification without opening any schema.

Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.

Usage Guidelines5/5

Does the description explain when to use this tool, when not to, or what alternatives exist?

Explicitly frames the two questions it answers ("is this device FDA cleared?" and "what has this competitor had cleared recently?") and names the exclusion: Class III goes to PMA with a pointer to fda_device_pma_approvals, and De Novo grants are not covered. That is a clear when-to-use / when-not-to-use / alternative triple.

Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.

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