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fda_device_510k

Read-onlyIdempotent

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.

Input Schema

TableJSON Schema
NameRequiredDescriptionDefault
limitNoMaximum rows to return (default 25, max 100).
queryNoManufacturer (applicant) name or device name search term.
end_dateNoInclusive ISO date upper bound (YYYY-MM-DD).
start_dateNoInclusive ISO date lower bound (YYYY-MM-DD).
product_codeNoOptional product code (e.g. 'DXJ' for ECG).

Schema Changelog

Changes observed during successful MCP inspections.

  1. Changed3 schema fields changed
    • addedInput schema / properties / limit / maximum
      Added value: +100
    • addedInput schema / properties / limit / minimum
      Added value: +1
    • changedInput schema / properties / limit / type
      Previous value: -"number"New value: +"integer"
  2. First observed

TDQS

A3.6/5.0
Behavior2/5

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

Annotations declare readOnlyHint=true, openWorldHint=true, idempotentHint=true, and destructiveHint=false, covering the safety profile. The description adds the filterable dimensions but says nothing about result cardinality, pagination behavior beyond the schema, or dataset scope/coverage. With annotations carrying safety, minimal added value.

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?

Three sentences, front-loaded with the resource and domain explanation, then filter fields, then use cases. Each sentence contributes, though the 510(k) pathway explainer is somewhat educational rather than operational.

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

Completeness3/5

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

For a read-only search tool with 100% schema coverage and no output schema, the description covers the necessary ground. However, it doesn't describe the result shape or clarify what 'query' matches (manufacturer OR device name, per schema), leaving some ambiguity for the agent.

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 coverage is 100%, so all five parameters are documented with types and descriptions in the schema. The description's mention of filter fields (manufacturer, device name, product code, decision date range) aligns with the schema, adding marginal context but no syntax or format detail beyond it. Baseline 3 applies.

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+resource: retrieving FDA 510(k) clearances for medical devices. It also explains the domain context (the 510(k) pathway for non-high-risk devices) and names the exact filterable fields, making it clearly distinguishable from siblings like fda_device_recalls.

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 names concrete use cases ('competitive intel, device R&D scouting, M&A research'), giving the agent a clear sense of when this tool applies. It lacks explicit when-not-to-use guidance or named alternatives, but the domain framing supplies sufficient context.

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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