Fda Devices

Fda Device 510k Search

fda_device_510k_search

Read-onlyIdempotent

Search FDA 510(k) premarket notifications by device, applicant, product code, K number, review panel, clearance type, decision, applicant location, third-party review status, or device-category text (via indication). Covers IN VITRO DIAGNOSTIC (IVD) tests and diagnostic devices, not just implants/hardware -- includes cleared molecular, genomic and companion diagnostic tests. Clearance means FDA found substantial equivalence; it is not an FDA approval or endorsement. indication is a BEST-EFFORT bridge, not a clinical-claim search: 510(k) records carry no indication/intended-use text at all, so it matches FDA's device CLASSIFICATION category name/definition instead (a product TYPE like "Insulin Pump", not a specific claim) and finds clearances under the matching product code(s) -- for a true clinical-indication text search (e.g. molecular/companion-diagnostic claims), use fda_device_pma_search's indication argument, which searches FDA's real approval-order narrative. Unknown arguments are rejected, not ignored. The most recent decision available lags roughly 2 weeks behind FDA's own site (openFDA's publishing cadence, not ours) -- do not treat this as same-day. total can exceed the 100-row limit cap; page further rows with skip.

Input Schema

TableJSON Schema

Name	Required	Description
`skip`	No	Row offset for paging past the 100-row limit cap (openFDA `skip`, max 25000), e.g. skip=100 with limit=100 returns rows 101-200.
`limit`	No	Results (1-100, default 20).
`device`	No	Device/trade name substring.
`to_date`	No	Latest decision date, YYYY-MM-DD.
`decision`	No	Exact decision text, e.g. "Substantially Equivalent".
`k_number`	No	Exact K number, e.g. K241234.
`applicant`	No	Applicant/company substring.
`from_date`	No	Earliest decision date, YYYY-MM-DD.
`indication`	No	One or more device-category phrases, OR'd together, matched against FDA's device classification name/definition (device/classification.json) to find matching product code(s), then 510(k)s under those codes -- a category match (e.g. "Insulin Pump"), NOT a search of clinical-claim text, because 510(k) has no such field. Pass several phrasings since matching is exact-phrase against the category wording. For an actual clinical-indication/intended-use text search, use fda_device_pma_search's indication argument instead.
`product_code`	No	Exact three-letter FDA product code.
`clearance_type`	No	Exact clearance type: Traditional, Special, or Abbreviated.
`applicant_state`	No	Applicant US state/territory code, e.g. "CA". Only populated for US applicants.
`applicant_country`	No	Applicant country, ISO 3166-1 alpha-2 code, e.g. "US" or "JP".
`advisory_committee`	No	FDA review panel name (exact), e.g. "Orthopedic" or "Microbiology".
`third_party_review`	No	true to keep only 510(k)s reviewed under FDA's third-party review program; false to exclude them.

Output Schema

TableJSON Schema

Name	Required	Description	Default
`total`	Yes
`source`	Yes
`returned`	Yes
`clearances`	Yes

Schema Changelog

Changes observed during successful MCP inspections.

Changed2 schema fields changedSep 28, 2026

changedInput schema / examples

Previous value: -[
-  {
-    "device": "glucose monitor",
-    "from_date": "2025-01-01",
-    "limit": 10
-  },
-  {
-    "advisory_committee": "Orthopedic",
-    "clearance_type": "Special",
-    "limit": 5
-  }
-]New value: +[
+  {
+    "device": "glucose monitor",
+    "from_date": "2025-01-01",
+    "limit": 10
+  },
+  {
+    "advisory_committee": "Orthopedic",
+    "clearance_type": "Special",
+    "limit": 5
+  },
+  {
+    "indication": [
+      "insulin pump"
+    ],
+    "limit": 5
+  }
+]

addedInput schema / properties / indication

Added value: +{
+  "description": "One or more device-category phrases, OR'd together, matched against FDA's device classification name/definition (device/classification.json) to find matching product code(s), then 510(k)s under those codes -- a category match (e.g. \"Insulin Pump\"), NOT a search of clinical-claim text, because 510(k) has no such field. Pass several phrasings since matching is exact-phrase against the category wording. For an actual clinical-indication/intended-use text search, use fda_device_pma_search's indication argument instead.",
+  "items": {
+    "type": "string"
+  },
+  "type": "array"
+}

Changed8 schema fields changedSep 17, 2026

changedInput schema / examples

Previous value: -[
-  {
-    "device": "glucose monitor",
-    "from_date": "2025-01-01",
-    "limit": 10
-  }
-]New value: +[
+  {
+    "device": "glucose monitor",
+    "from_date": "2025-01-01",
+    "limit": 10
+  },
+  {
+    "advisory_committee": "Orthopedic",
+    "clearance_type": "Special",
+    "limit": 5
+  }
+]

addedInput schema / properties / advisory_committee

Added value: +{
+  "description": "FDA review panel name (exact), e.g. \"Orthopedic\" or \"Microbiology\".",
+  "type": "string"
+}

addedInput schema / properties / applicant_country

Added value: +{
+  "description": "Applicant country, ISO 3166-1 alpha-2 code, e.g. \"US\" or \"JP\".",
+  "type": "string"
+}

addedInput schema / properties / applicant_state

Added value: +{
+  "description": "Applicant US state/territory code, e.g. \"CA\". Only populated for US applicants.",
+  "type": "string"
+}

addedInput schema / properties / clearance_type

Added value: +{
+  "description": "Exact clearance type: Traditional, Special, or Abbreviated.",
+  "type": "string"
+}

addedInput schema / properties / decision

Added value: +{
+  "description": "Exact decision text, e.g. \"Substantially Equivalent\".",
+  "type": "string"
+}

addedInput schema / properties / skip

Added value: +{
+  "description": "Row offset for paging past the 100-row limit cap (openFDA `skip`, max 25000), e.g. skip=100 with limit=100 returns rows 101-200.",
+  "type": "number"
+}

addedInput schema / properties / third_party_review

Added value: +{
+  "description": "true to keep only 510(k)s reviewed under FDA's third-party review program; false to exclude them.",
+  "type": "boolean"
+}

First observedJul 27, 2026

TDQS

A4.6/5.0

Behavior5/5

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

Adds substantial context beyond the annotations: clearance means substantial equivalence (not approval/endorsement), unknown arguments are rejected rather than ignored, results lag FDA by ~2 weeks, and total can exceed the 100-row cap requiring skip-based paging. These are exactly the behavioral traits annotations leave uncovered.

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?

Purpose and the key caveat are front-loaded and most sentences earn their place, but the paragraph is dense and the `indication` semantics are repeated across description and schema, adding mild redundancy.

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?

With an output schema present and 100% parameter coverage, the description fills the remaining gaps: the ambiguity of `indication`, the substantial-equivalence meaning, data-freshness caution, and paging behavior. An agent has everything needed to call it correctly.

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's explanation of `indication` largely restates the schema's own description, so it adds only marginal parameter-level value beyond what the structured field already provides.

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 (FDA 510(k) premarket notifications) and enumerates the searchable dimensions. It explicitly distinguishes itself from fda_device_pma_search and scopes the coverage to IVD/molecular/genomic tests, so an agent can tell it apart from siblings without opening a schema.

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

Usage Guidelines5/5

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

Gives explicit routing: use fda_device_pma_search's indication argument for a 'true clinical-indication text search', and use this tool's indication for device-category matching. It also clarifies when-not to use indication for clinical claims. Nothing is left to inference.

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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