{
  "code": "LHI",
  "deviceName": "Set, I.V. Fluid Transfer",
  "deviceClass": "II",
  "regulationNumber": "880.5440",
  "panel": "General Hospital",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 206,
    "last12Months": 5
  },
  "adverseEvents": {
    "total": 3833,
    "last12Months": 1096
  },
  "reviewDays": {
    "median": 89,
    "sampleSize": 206
  },
  "recalls": {
    "total": 61,
    "recent": [
      {
        "resNumber": "Z-1532-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Omnicell, Inc.",
        "firmAsPublished": "Omnicell, Inc.",
        "reason": "IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration.  The items were not shipped in a validated packing configuration and sterility cannot be ensured.",
        "initiated": "2025-02-20"
      },
      {
        "resNumber": "Z-0283-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "West Pharmaceutical Services AZ, Inc.",
        "firmAsPublished": "West Pharmaceutical Services AZ, Inc.",
        "reason": "Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.",
        "initiated": "2024-09-24"
      },
      {
        "resNumber": "Z-3082-2024",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Baxter Healthcare Corporation",
        "firmAsPublished": "Baxter Healthcare Corporation",
        "reason": "Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.",
        "initiated": "2024-08-20"
      },
      {
        "resNumber": "Z-3083-2024",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Baxter Healthcare Corporation",
        "firmAsPublished": "Baxter Healthcare Corporation",
        "reason": "Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.",
        "initiated": "2024-08-20"
      },
      {
        "resNumber": "Z-3084-2024",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Baxter Healthcare Corporation",
        "firmAsPublished": "Baxter Healthcare Corporation",
        "reason": "Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.",
        "initiated": "2024-08-20"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K252987",
      "deviceName": "ADRx™ Admixture Device",
      "applicant": "Epic Medical Pte. , Ltd.",
      "company": "Epic Medical Pte. , Ltd.",
      "decisionDate": "2026-06-12",
      "dateReceived": "2025-09-18"
    },
    {
      "kNumber": "K260301",
      "deviceName": "Vial Adapter",
      "applicant": "Hangzhou Qiantang Longyue Biotechnology Co., Ltd.",
      "company": "Hangzhou Qiantang Longyue Biotechnology Co., Ltd.",
      "decisionDate": "2026-06-05",
      "dateReceived": "2026-01-30"
    },
    {
      "kNumber": "K250345",
      "deviceName": "Medline Bag Decanter",
      "applicant": "Medline Industries, LP",
      "company": "Medline Industries, LP",
      "decisionDate": "2025-10-24",
      "dateReceived": "2025-02-06"
    },
    {
      "kNumber": "K251715",
      "deviceName": "FlowArt® Vial Access Device Vented",
      "applicant": "Asset Medikal",
      "company": "Asset Medikal",
      "decisionDate": "2025-10-14",
      "dateReceived": "2025-06-04"
    },
    {
      "kNumber": "K251676",
      "deviceName": "Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)",
      "applicant": "Microtek Medical, LLC",
      "company": "Microtek Medical, Inc.",
      "decisionDate": "2025-09-16",
      "dateReceived": "2025-05-30"
    },
    {
      "kNumber": "K243404",
      "deviceName": "HyHub™ and HyHub™ Duo Vial Access Devices",
      "applicant": "Takeda Pharmaceuticals",
      "company": "Takeda Pharmaceuticals",
      "decisionDate": "2025-07-18",
      "dateReceived": "2024-11-01"
    },
    {
      "kNumber": "K240761",
      "deviceName": "Arisure® Closed Male Luer with Spike Adapter (YM060)",
      "applicant": "Yukon Medical, LLC",
      "company": "Yukon Medical, LLC",
      "decisionDate": "2025-03-21",
      "dateReceived": "2024-03-20"
    },
    {
      "kNumber": "K243985",
      "deviceName": "Rio™ Drug Reconstitution Transfer Device",
      "applicant": "Icu Medical, Inc.",
      "company": "ICU Medical, Inc.",
      "decisionDate": "2025-01-22",
      "dateReceived": "2024-12-23"
    },
    {
      "kNumber": "K243486",
      "deviceName": "SmartSiteTM Vented Vial Access Device",
      "applicant": "Yukon Medical, LLC",
      "company": "Yukon Medical, LLC",
      "decisionDate": "2024-12-06",
      "dateReceived": "2024-11-08"
    },
    {
      "kNumber": "K241976",
      "deviceName": "nextaro® va, 15mm, 5µm",
      "applicant": "Sfm Medical Devices GmbH",
      "company": "Sfm Medical Devices GmbH",
      "decisionDate": "2024-09-06",
      "dateReceived": "2024-07-05"
    }
  ],
  "topApplicants": [
    {
      "name": "Medimop Medical Projects, Ltd.",
      "count": 11
    },
    {
      "name": "Baxter Healthcare Corp",
      "count": 10
    },
    {
      "name": "B.Braun Medical, Inc.",
      "count": 9
    },
    {
      "name": "Baxa Corp., Sub. of Cook Group, Inc.",
      "count": 7
    },
    {
      "name": "Carmel Pharma Ab.",
      "count": 7
    }
  ],
  "topCompanies": [
    {
      "name": "Baxter Healthcare Corporation",
      "count": 12,
      "spellings": 2
    },
    {
      "name": "Medimop Medical Projects Ltd.",
      "count": 11,
      "spellings": 1
    },
    {
      "name": "Baxa Corporation",
      "count": 10,
      "spellings": 2
    },
    {
      "name": "B. Braun Medical, Inc.",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Yukon Medical, LLC",
      "count": 8,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Epic Medical Pte. , Ltd.",
      "since": "2026-06-12",
      "kNumber": "K252987"
    },
    {
      "name": "Asset Medikal",
      "since": "2025-10-14",
      "kNumber": "K251715"
    },
    {
      "name": "Microtek Medical, Inc.",
      "since": "2025-09-16",
      "kNumber": "K251676"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 98,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 76,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 96,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 73,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 93,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 71,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 79,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 66,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 95,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 52,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 79,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 77,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 60,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 84,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 123,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 96,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 74,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 119,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 205,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 131,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 170,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 59,
        "expectedLow": 49.34475440617801,
        "expectedHigh": 205.73222228869594,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 127,
        "expectedLow": 26.99447350908286,
        "expectedHigh": 160.02043995339298,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 95,
        "expectedLow": 38.5294991232849,
        "expectedHigh": 193.22489220520097,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 115,
        "expectedLow": 34.77004636059611,
        "expectedHigh": 191.342067900402,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 72,
        "expectedLow": 38.552591412067436,
        "expectedHigh": 175.06300938389978,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 94,
        "expectedLow": 29.407847710333982,
        "expectedHigh": 171.7742376282973,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 96,
        "expectedLow": 42.99379541921211,
        "expectedHigh": 265.1861398198967,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 92,
        "expectedLow": 14.759126255719798,
        "expectedHigh": 191.21101975621323,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 99,
        "expectedLow": 15.594497563691405,
        "expectedHigh": 195.73524925816986,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 117,
        "expectedLow": 12.744532451359213,
        "expectedHigh": 195.45969767719646,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 186,
        "expectedLow": 30.594079622958095,
        "expectedHigh": 162.33282064439564,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 172,
        "expectedLow": 49.595979058799195,
        "expectedHigh": 224.7643587329713,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 201,
        "expectedLow": 70.82635185069766,
        "expectedHigh": 266.23072440717146,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 122,
        "expectedLow": 71.61458382332432,
        "expectedHigh": 232.8408481824391,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 116,
        "expectedLow": 73.117520523556,
        "expectedHigh": 239.0350794342489,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "LHI (Set, I.V. Fluid Transfer) has two findings, most consequential first. 3 first-time filers in the last 12 months, including Epic Medical Pte. , Ltd. and Asset Medikal (K252987, K251715, K251676). The code is crowded, scoring 79 of 100 — 99 companies hold a clearance here and 5 arrived in the last 12 months (LHI:crowding).",
    "severity": 43,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including Epic Medical Pte. , Ltd. and Asset Medikal",
        "recordIds": [
          "K252987",
          "K251715",
          "K251676"
        ],
        "severity": 43
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 79 of 100 — 99 companies hold a clearance here and 5 arrived in the last 12 months",
        "recordIds": [
          "LHI: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%3ALHI"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALHI"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ALHI"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ALHI"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ALHI"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ALHI"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ALHI"
    }
  ],
  "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": "2026-08-11T13:51:45.738Z"
}