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openfda

Search 510(k) premarket clearances

search_device_510k
Read-only

Search 510(k) premarket notification clearances: devices cleared for market as substantially equivalent to a predicate, with applicant, decision, product code and dates. openFDA device/510k endpoint.

Input Schema

TableJSON Schema
NameRequiredDescriptionDefault
skipNoNumber of records to skip, for pagination (0–25000; skip+limit reaches up to ~26000 records).
sortNoSort order, as `field:asc` or `field:desc`, e.g. 'receivedate:desc'.
limitNoMax number of records to return (1–1000). Omit for the API default of 1.
searchNoLucene-style query over this dataset's fields: 'field:term', AND with '+AND+', OR with a space, exact phrase via a '.exact' field suffix with quotes, ranges as '[low+TO+high]' (dates like '[20040101+TO+20081231]'). Example: openfda.device_name:"catheter"

Schema Changelog

Changes observed during successful MCP inspections.

  1. First observed

TDQS

B3.2/5.0
Behavior3/5

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

readOnlyHint=true already tells the agent this is a safe, non-mutating read. The description adds the dataset provenance ('openFDA device/510k endpoint') and enumerates returned fields, which is useful context, but says nothing about pagination behavior, rate limits, or result truncation. With annotations covering safety, a 3 is appropriate.

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?

Two sentences, front-loaded with the resource, then the domain explanation and data source. No wasted words, though the field enumeration ('applicant, decision, product code and dates') is slightly list-like filler for a search tool.

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 simple read-only search tool with a fully documented schema, no output schema, and readOnlyHint covering the safety profile, the description is adequate. It partially compensates for the missing output schema by indicating which fields the records carry, but does not describe result shape or pagination limits.

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 skip, sort, limit, and the Lucene-style search syntax are all fully documented in the schema. The description adds no parameter-level detail beyond that, so the baseline 3 is correct.

Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.

Purpose4/5

Does the description clearly state what the tool does and how it differs from similar tools?

States a specific verb (Search) and a well-defined resource (510(k) premarket notification clearances), and explains what a 510(k) clearance means ('devices cleared for market as substantially equivalent to a predicate'), which is genuinely clarifying domain context. It does not explicitly differentiate itself from device siblings like search_device_classification or search_device_events, but the resource is distinctive enough that an agent can tell them apart.

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

Usage Guidelines2/5

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

No guidance on when to use this tool versus alternatives such as search_device_classification, and no mention of prerequisites or expected query context. Usage is only implied by the resource name.

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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