{
  "code": "FOZ",
  "deviceName": "Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days",
  "deviceClass": "II",
  "regulationNumber": "880.5200",
  "panel": "General Hospital",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 506,
    "last12Months": 8
  },
  "adverseEvents": {
    "total": 14406,
    "last12Months": 3098
  },
  "reviewDays": {
    "median": 101,
    "sampleSize": 506
  },
  "recalls": {
    "total": 394,
    "recent": [
      {
        "resNumber": "Z-1914-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Arrow International, Inc., Division of Teleflex Medical Inc.",
        "firmAsPublished": "ARROW INTERNATIONAL, LLC",
        "reason": "Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured",
        "initiated": "2026-03-11"
      },
      {
        "resNumber": "Z-1783-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Cook Incorporated",
        "firmAsPublished": "Cook Incorporated",
        "reason": "Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.",
        "initiated": "2026-03-05"
      },
      {
        "resNumber": "Z-1788-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Cook Incorporated",
        "firmAsPublished": "Cook Incorporated",
        "reason": "Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.",
        "initiated": "2026-03-05"
      },
      {
        "resNumber": "Z-1789-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Cook Incorporated",
        "firmAsPublished": "Cook Incorporated",
        "reason": "Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.",
        "initiated": "2026-03-05"
      },
      {
        "resNumber": "Z-1407-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medline Industries, LP",
        "firmAsPublished": "Medline Industries, LP",
        "reason": "Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.",
        "initiated": "2026-01-07"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261041",
      "deviceName": "ClearSafe Closed System",
      "applicant": "MedSource Labs, LLC",
      "company": "MedSource Labs, LLC",
      "decisionDate": "2026-07-10",
      "dateReceived": "2026-03-31"
    },
    {
      "kNumber": "K260539",
      "deviceName": "MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter",
      "applicant": "MedSource Labs, LLC",
      "company": "MedSource Labs, LLC",
      "decisionDate": "2026-07-09",
      "dateReceived": "2026-02-17"
    },
    {
      "kNumber": "K253235",
      "deviceName": "Introcan Safety® Deep Access XL IV Catheter",
      "applicant": "B.Braun Medical, Inc.",
      "company": "B. Braun Medical, Inc.",
      "decisionDate": "2026-05-15",
      "dateReceived": "2025-09-29"
    },
    {
      "kNumber": "K252137",
      "deviceName": "BD Insyte™ IV Catheter",
      "applicant": "Becton Dickinson Infusion Therapy Systems, Inc.",
      "company": "Becton Dickinson Infusion Therapy Systems, Inc.",
      "decisionDate": "2026-04-02",
      "dateReceived": "2025-07-08"
    },
    {
      "kNumber": "K252513",
      "deviceName": "Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)",
      "applicant": "Poly Medicure Limited",
      "company": "Poly Medicure Limited",
      "decisionDate": "2026-04-01",
      "dateReceived": "2025-08-11"
    },
    {
      "kNumber": "K252398",
      "deviceName": "SURFLO Hybria Closed System Safety IV Catheter",
      "applicant": "Terumo Medical Products (Hangzhou) Co., Ltd.",
      "company": "Terumo Medical Products (Hangzhou) Co., Ltd.",
      "decisionDate": "2025-12-17",
      "dateReceived": "2025-07-31"
    },
    {
      "kNumber": "K252677",
      "deviceName": "Polyshield Safety IV Catheters",
      "applicant": "Poly Medicure Limited",
      "company": "Poly Medicure Limited",
      "decisionDate": "2025-11-05",
      "dateReceived": "2025-08-25"
    },
    {
      "kNumber": "K251422",
      "deviceName": "BD Saf-T-Intima™ Subcutaneous Catheter System",
      "applicant": "Becton Dickinson Infusion Therapy Systems, Inc.",
      "company": "Becton Dickinson Infusion Therapy Systems, Inc.",
      "decisionDate": "2025-10-08",
      "dateReceived": "2025-05-07"
    },
    {
      "kNumber": "K243403",
      "deviceName": "BD Nexiva™ Closed IV Catheter System",
      "applicant": "Becton Dickinson Infusion Therapy Systems, Inc.",
      "company": "Becton Dickinson Infusion Therapy Systems, Inc.",
      "decisionDate": "2025-07-25",
      "dateReceived": "2024-10-31"
    },
    {
      "kNumber": "K251155",
      "deviceName": "BD Cathena™ Safety IV Catheter",
      "applicant": "Becton Dickinson Infusion Therapy Systems, Inc.",
      "company": "Becton Dickinson Infusion Therapy Systems, Inc.",
      "decisionDate": "2025-07-11",
      "dateReceived": "2025-04-14"
    }
  ],
  "topApplicants": [
    {
      "name": "Becton Dickinson Infusion Therapy Systems, Inc.",
      "count": 30
    },
    {
      "name": "Menlo Care, Inc.",
      "count": 22
    },
    {
      "name": "Parke-Davis Co.",
      "count": 14
    },
    {
      "name": "B.Braun Medical, Inc.",
      "count": 12
    },
    {
      "name": "Becton Dickinson Vascular Access, Inc.",
      "count": 11
    }
  ],
  "topCompanies": [
    {
      "name": "Becton Dickinson Infusion Therapy Systems, Inc.",
      "count": 30,
      "spellings": 1
    },
    {
      "name": "Menlo Care, Inc.",
      "count": 22,
      "spellings": 1
    },
    {
      "name": "Parke-Davis Co.",
      "count": 14,
      "spellings": 1
    },
    {
      "name": "Cook Incorporated",
      "count": 13,
      "spellings": 2
    },
    {
      "name": "B. Braun Medical, Inc.",
      "count": 12,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Terumo Medical Products (Hangzhou) Co., Ltd.",
      "since": "2025-12-17",
      "kNumber": "K252398"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 295,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 255,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 495,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 309,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 364,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 426,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 299,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 436,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 382,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 308,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 332,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 335,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 330,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 428,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 435,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 427,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 427,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 349,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 460,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 486,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 457,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 350,
        "expectedLow": 298.0219689017743,
        "expectedHigh": 500.9457119759196,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 425,
        "expectedLow": 256.0517450036178,
        "expectedHigh": 414.6840802785636,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 438,
        "expectedLow": 303.8719155692498,
        "expectedHigh": 507.16746459839067,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 477,
        "expectedLow": 324.9921023445937,
        "expectedHigh": 533.316534353881,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 452,
        "expectedLow": 319.9011190209701,
        "expectedHigh": 513.6883255674975,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 454,
        "expectedLow": 337.14700393476204,
        "expectedHigh": 550.4758060425125,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 407,
        "expectedLow": 532.0900735569055,
        "expectedHigh": 869.6271426141735,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 407,
        "expectedLow": 299.8631623305507,
        "expectedHigh": 626.3803456771715,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 425,
        "expectedLow": 292.80759185755176,
        "expectedHigh": 644.59447821986,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 392,
        "expectedLow": 284.2685078070487,
        "expectedHigh": 623.4037363562549,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 433,
        "expectedLow": 230.5074937652034,
        "expectedHigh": 555.674163509584,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 347,
        "expectedLow": 271.4429985638138,
        "expectedHigh": 624.9216454872593,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 436,
        "expectedLow": 257.71214084489526,
        "expectedHigh": 704.2044687033095,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 380,
        "expectedLow": 202.95395116345412,
        "expectedHigh": 592.4637676512791,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 394,
        "expectedLow": 228.67410609893042,
        "expectedHigh": 630.309547507872,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1914-2026, Z-1783-2026, Z-1788-2026, Z-1789-2026, Z-1407-2026). 1 first-time filer in the last 12 months, Terumo Medical Products (Hangzhou) Co., Ltd (K252398). The code is crowded, scoring 83 of 100 — 211 companies hold a clearance here and 8 arrived in the last 12 months (FOZ:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1914-2026",
          "Z-1783-2026",
          "Z-1788-2026",
          "Z-1789-2026",
          "Z-1407-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Terumo Medical Products (Hangzhou) Co., Ltd.",
        "recordIds": [
          "K252398"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 83 of 100 — 211 companies hold a clearance here and 8 arrived in the last 12 months",
        "recordIds": [
          "FOZ: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%3AFOZ"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFOZ"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFOZ"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AFOZ"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AFOZ"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AFOZ"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AFOZ"
    }
  ],
  "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": "2026-08-11T13:51:45.697Z"
}