{
  "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": "2026-07-20",
    "results": {
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    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "SAK",
      "openfda": {
        "k_number": [
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          "K250680"
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      "review_panel": "GU",
      "medical_specialty": "HO",
      "device_name": "Software Device To Aid In The Prediction Or Diagnosis Of Sepsis",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "General Hospital",
      "device_class": "2",
      "definition": "A software device to aid in the prediction or diagnosis of sepsis uses advanced algorithms to analyze patient specific data to aid health care providers in the prediction and/or diagnosis of sepsis. The device is intended for adjunctive use and is not intended to be used as the sole determining factor in assessing a patient's sepsis status. The device may contain alarms that alert the care provider of the patient's status. The device is not intended to monitor response to treatment in patients being treated for sepsis.",
      "regulation_number": "880.6316",
      "implant_flag": "N",
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}