{
  "code": "FRN",
  "deviceName": "Pump, Infusion",
  "deviceClass": "II",
  "regulationNumber": "880.5725",
  "panel": "General Hospital",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 849,
    "last12Months": 2
  },
  "adverseEvents": {
    "total": 266469,
    "last12Months": 33398
  },
  "reviewDays": {
    "median": 83,
    "sampleSize": 849
  },
  "recalls": {
    "total": 718,
    "recent": [
      {
        "resNumber": "Z-2723-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "ICU Medical, Inc.",
        "firmAsPublished": "ICU Medical, Inc.",
        "reason": "In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.",
        "initiated": "2026-06-10"
      },
      {
        "resNumber": "Z-2724-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "ICU Medical, Inc.",
        "firmAsPublished": "ICU Medical, Inc.",
        "reason": "In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.",
        "initiated": "2026-06-10"
      },
      {
        "resNumber": "Z-2223-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Fresenius Kabi USA, LLC",
        "firmAsPublished": "Fresenius Kabi USA, LLC",
        "reason": "Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.",
        "initiated": "2026-05-06"
      },
      {
        "resNumber": "Z-2224-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Fresenius Kabi USA, LLC",
        "firmAsPublished": "Fresenius Kabi USA, LLC",
        "reason": "Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.",
        "initiated": "2026-05-06"
      },
      {
        "resNumber": "Z-2311-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "ICU Medical, Inc.",
        "firmAsPublished": "ICU Medical, Inc.",
        "reason": "Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.",
        "initiated": "2026-04-29"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253703",
      "deviceName": "RemunityPRO+ Pump for Remodulin® (treprostinil) Injection",
      "applicant": "Deka R&D Corp",
      "company": "Deka R&D Corp",
      "decisionDate": "2026-07-24",
      "dateReceived": "2025-11-24"
    },
    {
      "kNumber": "K252015",
      "deviceName": "FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing",
      "applicant": "Koru Medical Systems, Inc.",
      "company": "Koru Medical Systems, Inc.",
      "decisionDate": "2026-01-28",
      "dateReceived": "2025-06-27"
    },
    {
      "kNumber": "K251640",
      "deviceName": "SIGMA Spectrum Infusion Pump with Master Drug Library",
      "applicant": "Baxter Healthcare Corporation",
      "company": "Baxter Healthcare Corporation",
      "decisionDate": "2025-07-28",
      "dateReceived": "2025-05-29"
    },
    {
      "kNumber": "K251636",
      "deviceName": "Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)",
      "applicant": "Baxter Healthcare Corporation",
      "company": "Baxter Healthcare Corporation",
      "decisionDate": "2025-07-28",
      "dateReceived": "2025-05-29"
    },
    {
      "kNumber": "K242752",
      "deviceName": "MRidium 3870 MRI Infusion Pump System (3870)",
      "applicant": "Iradimed Corporation",
      "company": "Iradimed Corporation",
      "decisionDate": "2025-05-28",
      "dateReceived": "2024-09-12"
    },
    {
      "kNumber": "K243855",
      "deviceName": "BD Alaris Infusion System with Guardrails Suite MX",
      "applicant": "Carefusion 303, Inc.",
      "company": "Carefusion 303, Inc.",
      "decisionDate": "2025-04-25",
      "dateReceived": "2024-12-16"
    },
    {
      "kNumber": "K242115",
      "deviceName": "Plum Duo™ Precision IV Pump",
      "applicant": "Icu Medical, Inc.",
      "company": "ICU Medical, Inc.",
      "decisionDate": "2025-04-02",
      "dateReceived": "2024-07-19"
    },
    {
      "kNumber": "K242114",
      "deviceName": "Plum Solo™ Precision IV Pump",
      "applicant": "Icu Medical, Inc.",
      "company": "ICU Medical, Inc.",
      "decisionDate": "2025-04-02",
      "dateReceived": "2024-07-19"
    },
    {
      "kNumber": "K250357",
      "deviceName": "RemunityPRO™ Pump for Remodulin® (treprostinil) Injection",
      "applicant": "Deka Research & Development Corp.",
      "company": "Deka Research and Development Corporation",
      "decisionDate": "2025-03-11",
      "dateReceived": "2025-02-07"
    },
    {
      "kNumber": "K241736",
      "deviceName": "Remunity 2.0 Pump for Remodulin (treprostinil) Injection",
      "applicant": "Deka Research and Development Corp.",
      "company": "Deka Research and Development Corporation",
      "decisionDate": "2025-01-16",
      "dateReceived": "2024-06-17"
    }
  ],
  "topApplicants": [
    {
      "name": "Abbott Laboratories",
      "count": 66
    },
    {
      "name": "Baxter Healthcare Corp",
      "count": 39
    },
    {
      "name": "Y",
      "count": 26
    },
    {
      "name": "Travenol Laboratories, S.A.",
      "count": 23
    },
    {
      "name": "C.R. Bard, Inc.",
      "count": 22
    }
  ],
  "topCompanies": [
    {
      "name": "Abbott Laboratories, Inc.",
      "count": 67,
      "spellings": 2
    },
    {
      "name": "Baxter Healthcare Corporation",
      "count": 51,
      "spellings": 2
    },
    {
      "name": "Y",
      "count": 26,
      "spellings": 1
    },
    {
      "name": "Travenol Laboratories, S.A.",
      "count": 23,
      "spellings": 1
    },
    {
      "name": "C.R. Bard, Inc.",
      "count": 22,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Deka R&D Corp",
      "since": "2026-07-24",
      "kNumber": "K253703"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 8731,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 17447,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 19945,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 16854,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 15698,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 18197,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 14396,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 17309,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 12042,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 4467,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 6975,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 5408,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 5052,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 4680,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 4627,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 4461,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 3672,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 4352,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 5000,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 4818,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 4219,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 3563,
        "expectedLow": 2235.9623533437352,
        "expectedHigh": 6021.543636227943,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 3694,
        "expectedLow": 1756.3255316671532,
        "expectedHigh": 5201.820963111634,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 3848,
        "expectedLow": 2681.4253634809916,
        "expectedHigh": 5211.149756366321,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 4496,
        "expectedLow": 2969.416977698286,
        "expectedHigh": 5117.909690230929,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 4230,
        "expectedLow": 3068.6044831620634,
        "expectedHigh": 4750.63815495278,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 4320,
        "expectedLow": 3275.959867836192,
        "expectedHigh": 5042.707835496026,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 5124,
        "expectedLow": 5377.653771586598,
        "expectedHigh": 7812.9674539483985,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 4649,
        "expectedLow": 3594.738936614452,
        "expectedHigh": 5685.877733376789,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 4894,
        "expectedLow": 3968.0337288600813,
        "expectedHigh": 5830.09321066966,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 4986,
        "expectedLow": 3943.36773491608,
        "expectedHigh": 5796.801683219139,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 4025,
        "expectedLow": 3601.958614857657,
        "expectedHigh": 5243.162042109526,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 3864,
        "expectedLow": 3863.866896983044,
        "expectedHigh": 5650.498020450307,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 3623,
        "expectedLow": 3958.2378493416286,
        "expectedHigh": 6393.107791120659,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 4026,
        "expectedLow": 2618.7609642843518,
        "expectedHigh": 5371.879931845235,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 4735,
        "expectedLow": 2871.353444561354,
        "expectedHigh": 5898.45381377561,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "FRN (Pump, Infusion) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class I, Class II) (Z-2723-2026, Z-2724-2026, Z-2223-2026, Z-2224-2026, Z-2311-2026). 1 first-time filer in the last 12 months, Deka R&D Corp (K253703). The code is crowded, scoring 75 of 100 — 256 companies hold a clearance here and 2 arrived in the last 12 months (FRN:crowding).",
    "severity": 85,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class I, Class II)",
        "recordIds": [
          "Z-2723-2026",
          "Z-2724-2026",
          "Z-2223-2026",
          "Z-2224-2026",
          "Z-2311-2026"
        ],
        "severity": 85
      },
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Deka R&D Corp",
        "recordIds": [
          "K253703"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 75 of 100 — 256 companies hold a clearance here and 2 arrived in the last 12 months",
        "recordIds": [
          "FRN:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AFRN"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFRN"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFRN"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AFRN"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AFRN"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AFRN"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AFRN"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.698Z"
}