openFDA · Example Payload

Device 510K

FDAFood and Drug AdministrationDrug SafetyAdverse EventsDrug LabelsRecallsMedical DevicesFood SafetyTobaccoPublic HealthOpen DataGovernmentRegulatoryFAERSSPL

Device 510K is an example object payload from openFDA, with 2 top-level fields. It illustrates the shape of data this provider's APIs accept or return.

Top-level fields

metaresults

Example Payload

{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 175149
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Hialeah",
      "advisory_committee_description": "Hematology",
      "address_1": "440 Coulter Way",
      "address_2": "West 20th St.",
      "statement_or_summary": "",
      "product_code": "GKZ",
      "openfda": {
        "registration_number": [
          "1950302",
          "3010960914",
          "8040564",
          "2919069",
          "3004008703",
          "3009711478",
          "3016438761",
          "3006412379",
          "3005333358",
          "3007750372",
          "3006198300",
          "1000292377",
          "3007349751",
          "3016090200",
          "3009297077",
          "1415939",
          "3013059683",
          "3002809144",
          "1064608",
          "2221819",
          "3000148879",
          "3013608230",
          "3010421384",
          "8020888",
          "1036362",
          "3003601075",
          "3010324880",
          "1181121",
          "1832816",
          "2914537",
          "3014053517",
          "3003423869",
          "3002759288",
          "9613959",
          "3009156722",
          "3003589956",
          "3009092698",
          "1221433",
          "2032112",
          "2182501",
          "3008425728",
          "3009189893",
          "3013445220",
          "8023018",
          "3006946274",
          "3006606827",
          "1063851",
          "1017835",
          "3011765035",
          "3038625004",
          "1061932",
          "3027394506",
          "3007603826",
          "3020704087",
          "9610099",
          "3009834076",
          "3008096179",
          "3039523350",
          "3009495621",
          "3008352382",
          "3003630693",
          "2432235"
        ],
        "fei_number": [
          "1950302",
          "6137",
          "3010960914",
          "2919069",
          "3004008703",
          "3009711478",
          "3016438761",
          "3006412379",
          "3005333358",
          "3007750372",
          "3006198300",
          "1000292377",
          "3007019572",
          "3007349751",
          "3016090200",
          "3009297077",
          "3002808301",
          "1415939",
          "3013059683",
          "3002809144",
          "2221819",
          "3000148879",
          "3013608230",
          "3010421384",
          "3000203293",
          "1036362",
          "3003601075",
          "3010324880",
          "1181121",
          "1832816",
          "1000442352",
          "3014053517",
          "3003423869",
          "2914537",
          "3002759288",
          "3009156722",
          "3003589956",
          "1221433",
          "3009092698",
          "2182501",
          "3008425728",
          "3009189893",
          "3013445220",
          "3006946274",
          "3006606827",
          "1017835",
          "3002807272",
          "3011765035",
          "3038625004",
          "3027394506",
          "3007603826",
          "3020704087",
          "3003076831",
          "3009834076",
          "3008096179",
          "3002806778",
          "3039523350",
          "3009495621",
          "3008352382",
          "3003071743",
          "3003630693",
          "2432235"
        ],
        "device_name": "Counter, Differential Cell",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.5220",
        "device_class": "2"
      },
      "zip_code": "33010",
      "applicant": "Coulter Immunology",
      "decision_date": "1990-03-02",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "COULTER CLONE T4 MONOCLONAL ANTIBODY",
      "advisory_committee": "HE",
      "contact": "GREGORY  BUTCHKO",
      "expedited_review_flag": "",
      "k_number": "K893852",
      "state": "FL",
      "date_received": "1989-05-25",
      "review_advisory_committee": "HE",
      "postal_code": "33010",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}

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