Extract data from 510(k) submissions

A 510(k) is the premarket notification a company files with the US Food and Drug Administration to show that a new medical device is substantially equivalent to one already on the market. Clearance under section 510(k) is what lets most Class II devices reach patients, and the submission is built around one argument: that the new device is as safe and effective as a named predicate. Regulatory affairs leads assembling the file, a quality manager tracking the clearance, and a distributor confirming market authorization all read the same submission. When Corvus Medical Systems, Inc. files a 510(k) for the Corvus VeinView 3 vascular imaging system and the Food and Drug Administration clears it on 2026-06-12 under number K243918, the document records that a device may be sold. Identifiers on a 510(k) are what make it searchable and defensible. Its FDA K-number K243918, the three-letter product_code IYO, the regulation_number 21 CFR 892.1650, and the device_classification of Class II sit alongside the predicate device named by its own clearance number, here K221547 for the Meridian VascuScan II. A Traditional clearance_type, a decision_code of SESE for substantially equivalent, and the Radiology advisory_committee that reviewed it complete the header. Intended_use, the device_description, and the performance data summary form the technical core, while the substantial_equivalence flag records the finding the whole submission exists to obtain. Passed to Talonic, a 510(k) returns the K-number, the device and product codes, the predicate, and the equivalence decision as typed fields, keeping the predicate devices, applicable standards, and performance tests as tables. A submission cleared 2026-06-12 as K243918, substantially equivalent to K221547 under product code IYO, loads into a regulatory register as structured data rather than a scanned clearance letter. Because a 510(k) carries no patient information, it is not protected health information, and the regulatory fields return as written with no ruling on the equivalence determination.

What gets extracted from 510(k) submissions

How extraction works for 510(k) submissions

510(k) records arrive as FDA clearance letters, submission summaries, and openFDA exports rendered to PDF, so the K-number, the product code, and the predicate reference sit in different sections by document. Classification aligns the submission with the 510(k) schema in the Field Registry, which keeps the submission identity, the device classification, the predicate reference, and the decision distinct. Document_number is validated against the FDA K-number pattern, the product_code is read as its three-letter code and the regulation_number as its 21 CFR citation, and the substantial_equivalence boolean is captured alongside the decision_code so a Traditional clearance marked SESE is unambiguous. Predicate devices return as a table keyed by their own K-number and applicant, the applicable_standards table carries the ANSI, IEC, or ISO designations claimed, and the performance_tests table keeps each test with its method and result. Every value returns with a confidence score and a source-region pointer consistent with DIN SPEC 91491, so a regulatory lead can check the K-number or the predicate against the clearance. No patient data appears on a 510(k), and the regulatory fields are reported as written without ruling on substantial equivalence.

Sample extraction

An FDA 510(k) clearance for a Class II imaging device

{
  "document_number": "K243918",
  "document_date": "2026-02-18",
  "decision_date": "2026-06-12",
  "device_name": "Corvus VeinView 3 Vascular Imaging System",
  "device_classification": "Class II",
  "product_code": "IYO",
  "regulation_number": "21 CFR 892.1650",
  "clearance_type": "Traditional",
  "decision_code": "SESE",
  "predicate_device": "K221547",
  "substantial_equivalence": true,
  "intended_use": "Real-time visualization of peripheral veins to assist clinicians during venipuncture and vascular access",
  "submitter.name": "Corvus Medical Systems, Inc.",
  "submitter.address": "1400 Innovation Pkwy, Austin, TX 78758",
  "advisory_committee": "Radiology",
  "expedited_review_flag": false,
  "third_party_flag": false,
  "submission_status": "Cleared",
  "country_code": "US",
  "predicate_devices": [
    {
      "predicate_k_number": "K221547",
      "predicate_device_name": "Meridian VascuScan II",
      "predicate_applicant": "Meridian Imaging LLC"
    }
  ],
  "applicable_standards": [
    {
      "standard_number": "IEC 60601-1",
      "standard_title": "Medical electrical equipment, general requirements for basic safety",
      "compliance_status": "Met"
    },
    {
      "standard_number": "IEC 62304",
      "standard_title": "Medical device software life cycle processes",
      "compliance_status": "Met"
    }
  ]
}

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