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lzinga

US Government Open Data MCP

fda_device_510k

Read-only

Search over 174,000 FDA 510(k) premarket clearance decisions since 1976 to check if a medical device is substantially equivalent to a legally marketed device.

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
searchNoOpenFDA search query. Examples: 'field:value', 'field:"Exact Phrase"', 'field:[20200101+TO+20231231]', '_exists_:field'. Combine with '+AND+', '+OR+', '+NOT+'.
limitNoMax results (default 10, max 100)
Behavior3/5

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

Annotations already declare readOnlyHint=true, so no contradiction. The description adds that it searches over 174K records since 1976 and lists count fields, but does not disclose additional behavioral traits like rate limits, pagination behavior, or authentication requirements beyond what annotations provide.

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 very concise: two sentences of purpose followed by bullet-point examples and a line for count fields. Every sentence adds value; no fluff. Front-loaded with the core purpose.

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?

Given the tool is a search endpoint with no output schema, the description adequately covers the search capability, examples, and count fields. It is complete enough for an agent to understand how to formulate queries. However, it could mention that results are returned in a standard format (e.g., JSON) since no output schema is provided.

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 has 100% coverage with descriptions for both parameters (search and limit). The description adds significant value by providing concrete example search queries and listing count fields, which are not in the schema descriptions. This helps the agent understand valid search 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?

The description clearly states it searches 510(k) premarket clearance decisions, with a specific verb ('Search') and resource ('510(k) premarket clearance decisions'). It distinguishes from sibling FDA device tools by specifying a particular clearance type (510(k) vs. PMA, enforcement, recalls, etc.).

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 provides example search queries and mentions count fields, which guides usage. However, it does not explicitly state when to use this tool versus other FDA device tools (e.g., fda_device_pma, fda_device_recalls) or provide exclusions. Usage context is implied but not fully specified.

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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