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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. Changed1 schema field changed
    • changedInput schema / $schema
      Previous value: -"http://json-schema.org/draft-07/schema#"New value: +"https://json-schema.org/draft/2020-12/schema"
  2. First observed

TDQS

A3.7/5.0
Behavior3/5

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

Annotations already declare readOnlyHint=true, so the read-only safety profile is covered. The description adds the result-content context (applicant, decision, product code and dates) and names the underlying endpoint, but says nothing about pagination ceilings, default limit behavior, or result stability.

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?

One front-loaded sentence naming the verb, resource, record contents, and data source. The trailing 'openFDA device/510k endpoint' fragment is mildly redundant but not wasteful.

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?

For a read-only search tool with no output schema, the description usefully enumerates the fields returned, partially substituting for a missing return contract. Combined with fully documented parameters, an agent has enough to call it correctly, though pagination behavior is left to the schema.

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%, with each of the four parameters documented in the schema itself, including the Lucene syntax and pagination bounds. The description adds no parameter meaning beyond the schema, so the baseline of 3 applies.

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 (search) and resource (510(k) premarket notification clearances) and clarifies what these records represent — devices cleared as substantially equivalent to a predicate. This distinguishes it cleanly from siblings like search_device_classification, search_device_events, and search_device_recalls.

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 resource specificity implies when the tool applies, but there is no explicit when-to-use or when-not-to-use guidance, and no routing to sibling search tools despite a large family of device search endpoints being available.

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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