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lzinga

US Government Open Data MCP

by lzinga

fda_device_510k

Read-onlyIdempotent

Search FDA 510(k) premarket clearance decisions to verify if a medical device is substantially equivalent to a legally marketed device. Filter by device name, applicant, regulation number, or advisory committee.

Instructions

Search 510(k) premarket clearance decisions (174K+ since 1976). A 510(k) demonstrates a device is substantially equivalent to a legally marketed device.

Example searches:

  • 'advisory_committee:cv' — cardiovascular devices

  • 'openfda.regulation_number:868.5895' — by regulation number

  • 'device_name:"pacemaker"' — by device name

  • 'applicant:"Medtronic"' — by company

Count fields: country_code, advisory_committee, clearance_type.exact, decision_code

Input Schema

TableJSON Schema
NameRequiredDescriptionDefault
limitNoMax results (default 10, max 100)
searchNoOpenFDA search query. Examples: 'field:value', 'field:"Exact Phrase"', 'field:[20200101+TO+20231231]', '_exists_:field'. Combine with '+AND+', '+OR+', '+NOT+'.

Schema Changelog

Changes observed during successful MCP inspections.

  1. Changed1 schema field changedv2026.9.14
    • addedInput schema / properties / limit / default
      Added value: +10
  2. Changed1 schema field changedv2026.4.11
    • removedInput schema / additionalProperties
      Removed value: -false
  3. First observedv2026.3.9

TDQS

A3.8/5.0
Behavior3/5

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

Annotations already declare readOnlyHint, idempotentHint, and destructiveHint false, so the safety profile is established. The description adds context about dataset volume and the regulatory meaning of 510(k), but doesn't disclose response format, pagination behavior, or any other operational traits beyond what annotations imply.

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?

The description is appropriately sized and front-loaded with the primary action. The example searches and count fields are useful, and no sentence feels wasted, though the four examples could arguably be trimmed without losing core meaning.

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

Completeness4/5

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

For a two-parameter search tool with no output schema, the description provides sufficient orientation: what the data is, how to search, and which fields support counting. It could be more complete by noting response shape or API constraints, but nothing critical is missing for an agent to call it effectively.

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

Parameters4/5

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

Schema description coverage is 100% — both parameters have descriptions, including search syntax examples in the schema. The description enriches this by providing four real query examples and listing 'Count fields', which adds meaning for aggregation-style usage even though it isn't strictly parameter documentation.

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

Purpose4/5

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

The description opens with a specific verb and resource: 'Search 510(k) premarket clearance decisions', which clearly identifies what the tool does. However, it doesn't explicitly differentiate from sibling FDA tools like fda_device_pma or fda_device_classification, so it relies on the 510(k) term alone to distinguish them.

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

Usage Guidelines4/5

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

The description gives clear usage context: dataset scope (174K+ decisions since 1976), a brief regulatory definition, and concrete example searches for the 'search' parameter. It doesn't mention when not to use this tool or name alternatives, but the examples effectively show how to construct queries.

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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