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Fda Device 510k Search

fda_device_510k_search
Read-onlyIdempotent

Search FDA 510(k) premarket notifications by device, applicant, product code, or K number. Clearance means FDA found substantial equivalence; it is not an FDA approval or endorsement.

Input Schema

TableJSON Schema
NameRequiredDescriptionDefault
limitNoResults (1-100, default 20).
deviceNoDevice/trade name substring.
to_dateNoLatest decision date, YYYY-MM-DD.
k_numberNoExact K number, e.g. K241234.
applicantNoApplicant/company substring.
from_dateNoEarliest decision date, YYYY-MM-DD.
product_codeNoExact three-letter FDA product code.

Output Schema

TableJSON Schema
NameRequiredDescriptionDefault
totalYes
sourceYes
returnedYes
clearancesYes

Schema Changelog

Changes observed during successful MCP inspections. Dates show when Glama detected each change.

  1. First observed

TDQS

A4.1/5.0
Behavior4/5

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

Annotations indicate readOnlyHint, openWorldHint, idempotentHint, and destructiveHint=false. The description adds valuable context that 'clearance means FDA found substantial equivalence; it is not an FDA approval or endorsement,' which clarifies the meaning of results beyond the annotations. No contradictions with annotations.

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

Conciseness5/5

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

Two concise sentences: the first covers the action and criteria, the second clarifies the regulatory meaning. No wasted words or repetition.

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?

The description, combined with a complete schema (100% coverage) and an existing output schema, provides sufficient context for a search tool. It clarifies the meaning of clearance, which is critical for correct interpretation of results.

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%, so the schema already documents all 7 parameters. The description merely lists the searchable fields without adding new semantics or usage details beyond what the schema provides. Baseline 3 is appropriate.

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?

The description clearly states the verb ('Search') and the resource ('FDA 510(k) premarket notifications'), and lists specific search criteria (device, applicant, product code, K number). It distinguishes from sibling tools like fda_device_pma_search by focusing on 510(k) premarket notifications.

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

Usage Guidelines3/5

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

The description implicitly suggests usage for searching 510(k) clearance data, but lacks explicit guidance on when to use this tool versus alternatives such as fda_device_pma_search or fda_device_adverse_events. No 'when not to use' or exclusion conditions are provided.

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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