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FDA 510(k) Premarket Clearances

openfda_devices.clearance.premarket_510k
Read-onlyIdempotent

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.

Input Schema

TableJSON Schema
NameRequiredDescriptionDefault
skipNoNumber of records to skip for pagination (default 0).
limitNoNumber of records to return (1–99, default 10).
searchNoOpenFDA search expression using Lucene syntax. Single field: device_name:"pacemaker" or recall_status:"Ongoing". Combined: device_name:"insulin pump"+AND+recall_status:"Ongoing". Omit to return recent records sorted by date.

Output Schema

TableJSON Schema
NameRequiredDescriptionDefault
errorNoPresent only when the call failed. Includes error code, message, request_id, and any provider-specific extras.
resultNoTool response payload. Shape varies per tool — consult the tool description and inputSchema. May be an object, array, string, or number depending on the upstream provider response.

Schema Changelog

Changes observed during successful MCP inspections.

  1. First observed

TDQS

A4.7/5.0
Behavior5/5

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

Annotations already cover read-only, idempotent, non-destructive behavior, so the bar is lower. The description adds valuable behavioral nuance: what 'decision (SESE=cleared)' means, the regulatory meaning of a 510(k) clearance (substantially equivalent to a predicate device), and the data source/scope (175,000+ records, US public domain). No contradiction 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?

Four sentences packed with useful information: action, return fields, filter targets, regulatory meaning, use cases, and provenance. Front-loaded with the verb and resource, no filler, and each sentence earns its place.

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?

For a read-only, zero-required-param search tool with a full output schema and 100% schema parameter coverage, this description is complete. It covers what the tool returns, how to filter, why the data matters, and where it comes from. No critical gaps remain for an agent to invoke it correctly.

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?

The input schema fully documents skip, limit, and search with examples, so the baseline is 3. The description adds practical guidance by naming the specific searchable fields (device name, k-number, applicant, product code) and clearance type values (Traditional/Special/Abbreviated), which helps an agent construct meaningful Lucene queries beyond the schema's generic syntax.

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 ('Search FDA 510(k) premarket clearance submissions') and enumerates the return fields and filter dimensions, making the tool's scope unmistakable. It also differentiates from sibling tools in the openfda_devices namespace (recalls, adverse_events, classification) by name and content emphasis.

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?

Provides clear usage context ('Useful for market research, competitive analysis, and regulatory pathway planning') and describes what can be filtered (device name, k-number, applicant, product code). It does not explicitly name alternative tools or when-not-to-use conditions, but the context is strong enough for an agent to infer appropriate invocation.

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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