{
  "code": "KOD",
  "deviceName": "Catheter, Urological",
  "deviceClass": "II",
  "regulationNumber": "876.5130",
  "panel": "Gastroenterology, Urology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 238,
    "last12Months": 1
  },
  "adverseEvents": {
    "total": 3759,
    "last12Months": 668
  },
  "reviewDays": {
    "median": 64,
    "sampleSize": 238
  },
  "recalls": {
    "total": 107,
    "recent": [
      {
        "resNumber": "Z-2074-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "C.R. Bard, Inc.",
        "firmAsPublished": "C.R. Bard Inc",
        "reason": "Cather packaging may contain the incorrect French size.",
        "initiated": "2025-06-03"
      },
      {
        "resNumber": "Z-2075-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "C.R. Bard, Inc.",
        "firmAsPublished": "C.R. Bard Inc",
        "reason": "Cather packaging may contain the incorrect French size.",
        "initiated": "2025-06-03"
      },
      {
        "resNumber": "Z-1052-2024",
        "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-0227-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Teleflex, Inc.",
        "firmAsPublished": "TELEFLEX LLC",
        "reason": "Product may not be sterile",
        "initiated": "2022-09-20"
      },
      {
        "resNumber": "Z-0666-2022",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "C.R. Bard, Inc.",
        "firmAsPublished": "C.R. Bard Inc",
        "reason": "There is a potential to leak from the catheter where it connects to the drain bag",
        "initiated": "2022-01-27"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K251864",
      "deviceName": "Rubber Utility Catheter",
      "applicant": "C.R. Bard, Inc.",
      "company": "C.R. Bard, Inc.",
      "decisionDate": "2026-02-23",
      "dateReceived": "2025-06-17"
    },
    {
      "kNumber": "K220036",
      "deviceName": "Wellead Ureteral Catheter",
      "applicant": "Well Lead Medical Co., Ltd.",
      "company": "Well Lead Medical Co., Ltd.",
      "decisionDate": "2022-12-16",
      "dateReceived": "2022-01-05"
    },
    {
      "kNumber": "K220730",
      "deviceName": "allFlex Ureteral Catheters, Krait Ureteral Catheters",
      "applicant": "Allwin Medical Devices, Inc.",
      "company": "Allwin Medical Devices Pvt. Ltd.",
      "decisionDate": "2022-10-13",
      "dateReceived": "2022-03-14"
    },
    {
      "kNumber": "K211032",
      "deviceName": "Urinary Catheter 12 Fr, Urinary Catheter 16 Fr",
      "applicant": "Urogen Pharma, Ltd.",
      "company": "Urogen Pharma, Ltd.",
      "decisionDate": "2021-11-19",
      "dateReceived": "2021-04-07"
    },
    {
      "kNumber": "K181979",
      "deviceName": "Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter",
      "applicant": "Teleflexmedical, Inc.",
      "company": "Teleflexmedical, Inc.",
      "decisionDate": "2019-05-24",
      "dateReceived": "2018-07-25"
    },
    {
      "kNumber": "K180354",
      "deviceName": "UroGen Ureteral Catheter",
      "applicant": "Urogen Pharma, Ltd.",
      "company": "Urogen Pharma, Ltd.",
      "decisionDate": "2018-10-30",
      "dateReceived": "2018-02-08"
    },
    {
      "kNumber": "K181144",
      "deviceName": "Angled Tip Ureteral Catheter",
      "applicant": "Cook Incorporated",
      "company": "Cook Incorporated",
      "decisionDate": "2018-06-28",
      "dateReceived": "2018-05-01"
    },
    {
      "kNumber": "K180530",
      "deviceName": "Imager II Urology Torque Catheter",
      "applicant": "Boston Scientific Corporation",
      "company": "Boston Scientific Corporation",
      "decisionDate": "2018-04-10",
      "dateReceived": "2018-02-28"
    },
    {
      "kNumber": "K171810",
      "deviceName": "Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter",
      "applicant": "Cook Incorporated",
      "company": "Cook Incorporated",
      "decisionDate": "2018-03-07",
      "dateReceived": "2017-06-19"
    },
    {
      "kNumber": "K171600",
      "deviceName": "Renal Access Cobra Catheter, Kumpe Access Catheter",
      "applicant": "Cook Incorporated",
      "company": "Cook Incorporated",
      "decisionDate": "2018-02-16",
      "dateReceived": "2017-06-01"
    }
  ],
  "topApplicants": [
    {
      "name": "C.R. Bard, Inc.",
      "count": 10
    },
    {
      "name": "Abco Dealers, Inc.",
      "count": 9
    },
    {
      "name": "Van-Tec, Inc.",
      "count": 8
    },
    {
      "name": "The Kendal Co.",
      "count": 7
    },
    {
      "name": "American Pharmaseal Div. Ahsc",
      "count": 6
    }
  ],
  "topCompanies": [
    {
      "name": "C.R. Bard, Inc.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Abco Dealers, Inc.",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Van-Tec, Inc.",
      "count": 8,
      "spellings": 1
    },
    {
      "name": "The Kendal Co.",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "American Pharmaseal Div. Ahsc",
      "count": 6,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 51,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 115,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 93,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 111,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 117,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 91,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 99,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 69,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 90,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 148,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 88,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 81,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 96,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 101,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 87,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 76,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 71,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 100,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 91,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 109,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 211,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 95,
        "expectedLow": 49.06452473747724,
        "expectedHigh": 188.0926134995207,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 94,
        "expectedLow": 40.96241781211635,
        "expectedHigh": 151.9158268737314,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 246,
        "expectedLow": 44.76943205046163,
        "expectedHigh": 169.29189191861468,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 106,
        "expectedLow": 43.83865804626529,
        "expectedHigh": 264.02351997935364,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 82,
        "expectedLow": 27.79975984283758,
        "expectedHigh": 233.87635460157202,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 174,
        "expectedLow": 13.064841340022838,
        "expectedHigh": 227.75269460221216,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 138,
        "expectedLow": 36.5908117302771,
        "expectedHigh": 391.55918500800897,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 62,
        "expectedLow": 13.822950319452863,
        "expectedHigh": 275.14012864811286,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 101,
        "expectedLow": 0,
        "expectedHigh": 266.3394920900874,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 71,
        "expectedLow": 0,
        "expectedHigh": 258.00839086945115,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 92,
        "expectedLow": 0,
        "expectedHigh": 223.54953373271715,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 79,
        "expectedLow": 0,
        "expectedHigh": 250.05671306081925,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 126,
        "expectedLow": 0,
        "expectedHigh": 268.60486014200535,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 86,
        "expectedLow": 0,
        "expectedHigh": 231.66944975959154,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 69,
        "expectedLow": 0,
        "expectedHigh": 254.6746698678887,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "KOD (Catheter, Urological): 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%3AKOD"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKOD"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AKOD"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AKOD"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AKOD"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AKOD"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AKOD"
    }
  ],
  "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"
}