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sapientsai

OpenFDA MCP Server

by sapientsai

search_device_510k

Search FDA 510(k) premarket notifications to find medical device clearances by device name, applicant, or product code. Returns clearance decisions and classification details.

Instructions

Search FDA 510(k) premarket notification database for medical device clearances. Find device clearances by device name, applicant, product code, clearance type, or decision date. Returns clearance decisions and device classification details.

Input Schema

TableJSON Schema
NameRequiredDescriptionDefault
skipNoNumber of results to skip for pagination
limitNoMaximum results to return (1-100, default 10)
applicantNoApplicant/company name
deviceNameNoDevice name to search
productCodeNoFDA product code
clearanceTypeNoClearance type (e.g., 'Traditional', 'Special')
decisionDateToNoDecision date range end (YYYY-MM-DD)
decisionDateFromNoDecision date range start (YYYY-MM-DD)
Behavior3/5

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

Without annotations, the description carries the full burden of behavioral disclosure. It states the tool returns clearance decisions and classification details, suggesting a read-oriented operation, but does not disclose potential rate limits, authentication requirements, or behavior when no results are found. A score of 3 reflects adequate but not thorough transparency.

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?

The description is two sentences with no unnecessary words. The first sentence conveys the core purpose and database, and the second lists search fields and output. It is front-loaded and efficient.

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?

With 8 parameters fully described in the schema and no output schema, the description adequately explains the tool's purpose and return type. It could briefly mention pagination (skip/limit) but this is already in the schema. Overall, the context is sufficient for selecting the tool.

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 baseline is 3. The description mentions specific search criteria (device name, applicant, product code, etc.) but does not add meaning beyond the schema's parameter descriptions. No additional semantic context is provided.

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 tool searches the FDA 510(k) premarket notification database for medical device clearances, specifying searchable fields (device name, applicant, product code, etc.) and return content (clearance decisions and classification details). This explicitly differentiates it from sibling tools like search_device_adverse_events or search_device_classifications.

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 implies when to use the tool (searching for 510(k) clearances) but does not provide explicit guidance on when to use alternatives, prerequisites, or when not to use it. No exclusions or alternative recommendations are given.

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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