{
  "code": "KNX",
  "deviceName": "Collector, Urine, (And Accessories) For Indwelling Catheter",
  "deviceClass": "II",
  "regulationNumber": "876.5250",
  "panel": "Gastroenterology, Urology",
  "definition": null,
  "submissionTypeId": "4",
  "submissionType": "510(k)",
  "clearances": {
    "total": 206,
    "last12Months": 0
  },
  "adverseEvents": {
    "total": 528,
    "last12Months": 119
  },
  "reviewDays": {
    "median": 45,
    "sampleSize": 206
  },
  "recalls": {
    "total": 19,
    "recent": [
      {
        "resNumber": "Z-1046-2024",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Cardinal Health 200, LLC",
        "firmAsPublished": "Cardinal Health 200, LLC",
        "reason": "Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.",
        "initiated": "2023-12-04"
      },
      {
        "resNumber": "Z-1974-2019",
        "status": "Terminated",
        "recallClass": "Class III",
        "firm": "Teleflex Medical",
        "firmAsPublished": "Teleflex Medical",
        "reason": "The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely to affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.",
        "initiated": "2019-01-14"
      },
      {
        "resNumber": "Z-1975-2019",
        "status": "Terminated",
        "recallClass": "Class III",
        "firm": "Teleflex Medical",
        "firmAsPublished": "Teleflex Medical",
        "reason": "The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.",
        "initiated": "2019-01-14"
      },
      {
        "resNumber": "Z-2872-2017",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "C.R. Bard, Inc.",
        "firmAsPublished": "C.R. Bard, Inc.",
        "reason": "Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.",
        "initiated": "2017-06-02"
      },
      {
        "resNumber": "Z-0967-2017",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "C.R. Bard, Inc.",
        "firmAsPublished": "C.R. Bard, Inc.",
        "reason": "The product contained a latex catheter instead of a silicone catheter.",
        "initiated": "2016-07-11"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K110518",
      "deviceName": "IBAG",
      "applicant": "Future Path Medical, LLC",
      "company": "Future Path Medical, LLC",
      "decisionDate": "2011-06-24",
      "dateReceived": "2011-02-23"
    },
    {
      "kNumber": "K973364",
      "deviceName": "4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG",
      "applicant": "Maersk Medical A/S",
      "company": "Maersk Medical A/S",
      "decisionDate": "1998-03-17",
      "dateReceived": "1997-09-08"
    },
    {
      "kNumber": "K972887",
      "deviceName": "MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG",
      "applicant": "Medline Industries, Inc.",
      "company": "Medline Industries, LP",
      "decisionDate": "1997-12-11",
      "dateReceived": "1997-08-05"
    },
    {
      "kNumber": "K971271",
      "deviceName": "BESECURE EXTERNAL URINARY COLLECTION SYSTEM",
      "applicant": "Urology Research Intl., Inc.",
      "company": "Urology Research Intl., Inc.",
      "decisionDate": "1997-08-18",
      "dateReceived": "1997-04-04"
    },
    {
      "kNumber": "K971929",
      "deviceName": "AMSINO URINARY LEG BAG",
      "applicant": "Amsino Intl., Inc.",
      "company": "Amsino Intl., Inc.",
      "decisionDate": "1997-08-06",
      "dateReceived": "1997-05-27"
    },
    {
      "kNumber": "K971764",
      "deviceName": "WELCON HUE-VU URINARY DRAINAGE BAG",
      "applicant": "Welcon, Inc.",
      "company": "Welcon, Inc.",
      "decisionDate": "1997-07-29",
      "dateReceived": "1997-05-13"
    },
    {
      "kNumber": "K964690",
      "deviceName": "LIBERTY VALVE",
      "applicant": "Cleveland Medical Devices, Inc.",
      "company": "Cleveland Medical Devices, Inc.",
      "decisionDate": "1997-03-21",
      "dateReceived": "1996-11-22"
    },
    {
      "kNumber": "K964745",
      "deviceName": "AMSINO URINARY DRAINAGE BAG",
      "applicant": "Amsino Intl., Inc.",
      "company": "Amsino Intl., Inc.",
      "decisionDate": "1997-03-18",
      "dateReceived": "1996-11-26"
    },
    {
      "kNumber": "K962652",
      "deviceName": "URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)",
      "applicant": "Customed, Inc.",
      "company": "Customed, Inc",
      "decisionDate": "1996-10-04",
      "dateReceived": "1996-07-08"
    },
    {
      "kNumber": "K960949",
      "deviceName": "PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167",
      "applicant": "Bristol-Myers Squibb",
      "company": "Bristol-Myers Squibb",
      "decisionDate": "1996-04-19",
      "dateReceived": "1996-03-11"
    }
  ],
  "topApplicants": [
    {
      "name": "Bio D Corp.",
      "count": 9
    },
    {
      "name": "Conphar, Inc.",
      "count": 6
    },
    {
      "name": "The Kendal Co.",
      "count": 6
    },
    {
      "name": "Coloplast A/S",
      "count": 5
    },
    {
      "name": "Concord Laboratories, Inc.",
      "count": 5
    }
  ],
  "topCompanies": [
    {
      "name": "Bio D Corp.",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Conphar, Inc.",
      "count": 6,
      "spellings": 1
    },
    {
      "name": "The Kendal Co.",
      "count": 6,
      "spellings": 1
    },
    {
      "name": "Coloplast A.S.",
      "count": 5,
      "spellings": 1
    },
    {
      "name": "Concord Laboratories, Inc.",
      "count": 5,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 22,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 22,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 17,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 23,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
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        "isSufficient": true
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      {
        "month": "2025-02-01",
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        "expectedHigh": 18.440270320373607,
        "isSufficient": true
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        "month": "2025-03-01",
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        "expectedLow": 4.03649203943709,
        "expectedHigh": 19.775841522263615,
        "isSufficient": true
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      {
        "month": "2025-04-01",
        "observed": 18,
        "expectedLow": 5.732323603607973,
        "expectedHigh": 20.912534410468165,
        "isSufficient": true
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      {
        "month": "2025-05-01",
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        "expectedLow": 6.312080290705869,
        "expectedHigh": 21.310036620165185,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 18,
        "expectedLow": 6.424830074993433,
        "expectedHigh": 21.715530619254352,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 31,
        "expectedLow": 11.625051486734812,
        "expectedHigh": 36.583631388738254,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 19,
        "expectedLow": 9.745444134812402,
        "expectedHigh": 29.76472493995434,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 18,
        "expectedLow": 9.921109128819444,
        "expectedHigh": 31.046760381979816,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 14,
        "expectedLow": 9.215742150024143,
        "expectedHigh": 29.858971957971843,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 17,
        "expectedLow": 7.874651928505427,
        "expectedHigh": 24.503320456762083,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 13,
        "expectedLow": 9.268836597991783,
        "expectedHigh": 27.406134988081547,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 14,
        "expectedLow": 9.11361810017783,
        "expectedHigh": 29.01982288335384,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 17,
        "expectedLow": 7.181688600673466,
        "expectedHigh": 22.618922079319784,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 11,
        "expectedLow": 9.02791914850349,
        "expectedHigh": 25.164461435088263,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "KNX (Collector, Urine, (And Accessories) For Indwelling Catheter): nothing changed in the six FDA sources we watch.",
    "severity": 1,
    "factors": [],
    "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%3AKNX"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKNX"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKNX"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKNX"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKNX"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKNX"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKNX"
    }
  ],
  "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": "2026-08-11T13:51:45.734Z"
}