FDA 510(k) Device Clearance Landscape Report

Medtech competitive-intelligence, regulatory-operations, and portfolio-strategy teams enter bounded 510(k) watches for applicants, product codes, device names, specialties, or dates. The Actor queries the official openFDA device/510k API and compares each public record with an isolated recurring baseline. It returns source-linked clearance change alerts, applicant/product-code/specialty landscape reports, and JSON exports; baseline and unchanged checks emit zero rows and zero charges.

Store Quickstart

1. Start with initialRunMode: "baseline_only" to establish a free snapshot.
2. Run the same monitorKey later with generateReport: true and emitUnchanged: false.
3. Use initialRunMode: "emit_backfill" only when you explicitly want the current matching records and a paid report immediately.

The Actor uses https://api.fda.gov/device/510k.json. An openFDA API key is optional; normal bounded runs work without one. The optional openfdaApiKey input is never written to output or monitor state.

Input Examples

1. Product-code watch

{
  "watches": [{
    "id": "diagnostic-imaging",
    "productCodes": ["LLZ"],
    "decisionDateFrom": "2026-01-01",
    "decisionDateTo": "2026-12-31"
  }],
  "monitorKey": "diagnostic-imaging-2026",
  "initialRunMode": "baseline_only",
  "generateReport": true,
  "emitUnchanged": false,
  "maxRecordsPerWatch": 100,
  "maxChargeUsd": 25
}

2. Applicant and specialty watch

{
  "watches": [{
    "id": "company-radiology",
    "applicants": ["Example Device Company"],
    "medicalSpecialties": ["Radiology"],
    "decisionDateFrom": "2025-01-01",
    "decisionDateTo": "2026-12-31"
  }],
  "monitorKey": "company-radiology-watch",
  "initialRunMode": "emit_backfill",
  "generateReport": true,
  "emitExport": true,
  "emitRawRows": false,
  "maxChargeUsd": 25
}

3. Device and review-panel watch

{
  "watches": [{
    "id": "portable-device-panel",
    "deviceNames": ["portable monitor"],
    "reviewPanels": ["Cardiovascular"],
    "clearanceTypes": ["Traditional"]
  }],
  "monitorKey": "portable-device-panel",
  "initialRunMode": "baseline_only",
  "generateReport": true,
  "emitUnchanged": false
}

Output

The primary value rows are:

• fda-clearance-change-alert: one source-linked alert for a new or changed public record.
• fda-clearance-landscape-report: an aggregate grouped by applicant, product code, specialty, decision date, and review panel.
• fda-clearance-export: a compact JSON-ready set of normalized records.
• fda-510k-row: optional low-priced normalized record rows when emitRawRows is true.

Normalized records contain public analysis fields such as kNumber, applicant, deviceName, productCode, medicalSpecialty, decisionDate, decisionCode, clearanceType, reviewPanel, and regulationNumbers. Direct communication and contact fields are not emitted.

See docs/sample-output.json for a representative alert, report, export, and row payload. It is illustrative and is not a live FDA result.

Pricing

Event	Price	When it is emitted
fda-510k-row	$0.004	Optional normalized row for a new or changed record
fda-clearance-change-alert	$0.20	New or changed record is detected
fda-clearance-landscape-report	$10.00	An explicit change set is summarized
fda-clearance-export	$6.00	An explicit change set is exported

There is no start charge. A first baseline_only run saves state and emits 0 rows / 0 charge. A later unchanged run also emits 0 rows / 0 charge, regardless of emitUnchanged. maxChargeUsd is checked before any row is pushed; a state-save failure fails closed and does not report a successful run.

Compliance Guardrails

• Official public openFDA device/510k data only; no login, browser session, proxy, or bypass is used.
• Public applicant and product names are retained for record analysis, not for person enrichment or contact workflows.
• The Actor does not provide medical, legal, regulatory, compliance, investment, procurement, or market-access advice.
• It does not claim FDA endorsement, approval superiority, safety, efficacy, causality, or clearance likelihood.
• Verify the official source record and consult qualified professionals before making a decision.

See docs/source-compliance.md for source scope and limitations.

Run the next report

• FDA Orange Book Patent & Exclusivity Change Report for public drug patent, exclusivity, and product-lifecycle change reporting.
• Product Safety Market Action Portfolio Report for CPSC and NHTSA public market-action evidence.
• FDA Drug Shortage Supply Change Report for source-linked public drug-shortage changes and supply reports.

Source

• openFDA 510(k) endpoint
• openFDA 510(k) API guide
• openFDA 510(k) searchable fields