{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QFG",
      "openfda": {
        "k_number": [
          "K234027",
          "K253743",
          "K253470",
          "K231826",
          "K213536",
          "K241078",
          "K201214",
          "K203768",
          "K250792",
          "K213134",
          "K223846",
          "K203234",
          "K240309",
          "K252770",
          "K233952",
          "K191679",
          "K232380",
          "K241178",
          "K231485",
          "K223213",
          "K250930",
          "K233044",
          "K253074",
          "K251032",
          "DEN180058",
          "K230545"
        ],
        "registration_number": [
          "3032746481",
          "3005627859",
          "1220477",
          "3019807891",
          "3019004087",
          "2030624",
          "1220973",
          "3014197758",
          "3010291427",
          "2032227",
          "3015192982",
          "3008824097",
          "2246552",
          "3042027705",
          "2219920",
          "3014585508",
          "2029275",
          "2032098",
          "3026266833",
          "2030598",
          "3030970576",
          "3016798778",
          "3016540876",
          "3007981285",
          "3013756811",
          "3016245399"
        ],
        "fei_number": [
          "3032746481",
          "3005627859",
          "1220477",
          "3019807891",
          "3019004087",
          "1220973",
          "3014197758",
          "3010291427",
          "3015192982",
          "3008824097",
          "2246552",
          "3042027705",
          "2219920",
          "3014585508",
          "1000306431",
          "3026266833",
          "1000518731",
          "3030970576",
          "3016798778",
          "3016540876",
          "3007981285",
          "3013756811",
          "3003166194",
          "3000206435",
          "3003058448",
          "3016245399"
        ]
      },
      "review_panel": "CH",
      "medical_specialty": "CH",
      "device_name": "Alternate Controller Enabled Insulin Infusion Pump",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Clinical Chemistry",
      "device_class": "2",
      "definition": "An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices, such as automated insulin dosing systems, to allow insulin delivery commands to be received, executed, and confirmed. ACE insulin pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of insulin delivery.",
      "regulation_number": "880.5730",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}