{
  "code": "DTZ",
  "deviceName": "Oxygenator, Cardiopulmonary Bypass",
  "deviceClass": "II",
  "regulationNumber": "870.4350",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 254,
    "last12Months": 4
  },
  "adverseEvents": {
    "total": 2503,
    "last12Months": 892
  },
  "reviewDays": {
    "median": 88,
    "sampleSize": 254
  },
  "recalls": {
    "total": 107,
    "recent": [
      {
        "resNumber": "Z-0487-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medtronic Perfusion Systems",
        "firmAsPublished": "Medtronic Perfusion Systems",
        "reason": "Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.",
        "initiated": "2025-09-12"
      },
      {
        "resNumber": "Z-1076-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Maquet Medical Systems, Usa",
        "firmAsPublished": "Maquet Medical Systems USA",
        "reason": "The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.",
        "initiated": "2024-01-16"
      },
      {
        "resNumber": "Z-1077-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Maquet Medical Systems, Usa",
        "firmAsPublished": "Maquet Medical Systems USA",
        "reason": "The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.",
        "initiated": "2024-01-16"
      },
      {
        "resNumber": "Z-1634-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Maquet Medical Systems, Usa",
        "firmAsPublished": "Maquet Medical Systems USA",
        "reason": "1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch.\n2. Product packaging may exhibit holes, cracks, dents, and crushed areas. \n\nBoth issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.",
        "initiated": "2023-05-18"
      },
      {
        "resNumber": "Z-1635-2023",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Maquet Medical Systems, Usa",
        "firmAsPublished": "Maquet Medical Systems USA",
        "reason": "1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory s sterile pouch.\n2. Product packaging may exhibit holes, cracks, dents, and crushed areas. \n\nBoth issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.",
        "initiated": "2023-05-18"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253838",
      "deviceName": "Lifemotion Disposable Membrane Oxygenator",
      "applicant": "Lifemotion Medical Technology Co., Ltd.",
      "company": "Lifemotion Medical Technology Co., Ltd.",
      "decisionDate": "2026-03-16",
      "dateReceived": "2025-12-01"
    },
    {
      "kNumber": "K240934",
      "deviceName": "Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);",
      "applicant": "Spectrum Medical S.R.L.",
      "company": "Spectrum Medical S.R.L.",
      "decisionDate": "2026-03-12",
      "dateReceived": "2024-04-05"
    },
    {
      "kNumber": "K250821",
      "deviceName": "Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)",
      "applicant": "Eurosets S.R.L",
      "company": "Eurosets s.r.l.",
      "decisionDate": "2025-12-12",
      "dateReceived": "2025-03-18"
    },
    {
      "kNumber": "K242503",
      "deviceName": "Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)",
      "applicant": "Eurosets S.R.L",
      "company": "Eurosets s.r.l.",
      "decisionDate": "2025-11-24",
      "dateReceived": "2024-08-22"
    },
    {
      "kNumber": "K231982",
      "deviceName": "Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2",
      "applicant": "Qura S.R.L",
      "company": "QURA S.R.L.",
      "decisionDate": "2024-09-12",
      "dateReceived": "2023-07-05"
    },
    {
      "kNumber": "K240666",
      "deviceName": "Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)",
      "applicant": "Medtronic Perfusion Systems",
      "company": "Medtronic Perfusion Systems",
      "decisionDate": "2024-07-10",
      "dateReceived": "2024-03-08"
    },
    {
      "kNumber": "K241352",
      "deviceName": "Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir  (541B)",
      "applicant": "Medtronic, Inc.",
      "company": "Medtronic, Inc.",
      "decisionDate": "2024-06-12",
      "dateReceived": "2024-05-13"
    },
    {
      "kNumber": "K231652",
      "deviceName": "D100 KIDS; D101 KIDS",
      "applicant": "Sorin Group Italia S.R.L.",
      "company": "Sorin Group Italia S.r.l.",
      "decisionDate": "2023-11-16",
      "dateReceived": "2023-06-06"
    },
    {
      "kNumber": "K231773",
      "deviceName": "Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U",
      "applicant": "Qura S.R.L",
      "company": "QURA S.R.L.",
      "decisionDate": "2023-11-08",
      "dateReceived": "2023-06-16"
    },
    {
      "kNumber": "K231414",
      "deviceName": "CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)",
      "applicant": "Chalice Medical , Ltd.",
      "company": "Chalice Medical , Ltd.",
      "decisionDate": "2023-11-01",
      "dateReceived": "2023-05-16"
    }
  ],
  "topApplicants": [
    {
      "name": "Sorin Group Italia S.R.L.",
      "count": 22
    },
    {
      "name": "Medtronic, Inc.",
      "count": 15
    },
    {
      "name": "American Bentley",
      "count": 13
    },
    {
      "name": "Maquet Cardiopulmonary, AG",
      "count": 13
    },
    {
      "name": "Medtronic Vascular",
      "count": 12
    }
  ],
  "topCompanies": [
    {
      "name": "Sorin Group Italia S.r.l.",
      "count": 22,
      "spellings": 1
    },
    {
      "name": "Medtronic, Inc.",
      "count": 16,
      "spellings": 2
    },
    {
      "name": "American Bentley",
      "count": 13,
      "spellings": 1
    },
    {
      "name": "Maquet Cardiopulmonary Gmbh",
      "count": 13,
      "spellings": 1
    },
    {
      "name": "Medtronic Vascular",
      "count": 12,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Lifemotion Medical Technology Co., Ltd.",
      "since": "2026-03-16",
      "kNumber": "K253838"
    },
    {
      "name": "Spectrum Medical S.R.L.",
      "since": "2026-03-12",
      "kNumber": "K240934"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 67,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 50,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 49,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 64,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 67,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 148,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 50,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 62,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 48,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 46,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 47,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 41,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 55,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 53,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 34,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 45,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 29,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 31,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 58,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 56,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 40,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 42,
        "expectedLow": 22.246641966422622,
        "expectedHigh": 59.75339510596647,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 53,
        "expectedLow": 19.710739297630024,
        "expectedHigh": 52.27702361001327,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 61,
        "expectedLow": 24.877673002755554,
        "expectedHigh": 66.96288572705117,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 75,
        "expectedLow": 27.885153207269383,
        "expectedHigh": 76.7940921705841,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 67,
        "expectedLow": 27.824013510110156,
        "expectedHigh": 82.93389892898071,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 56,
        "expectedLow": 29.078678105492937,
        "expectedHigh": 92.59550647917028,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 79,
        "expectedLow": 44.470491413962634,
        "expectedHigh": 142.43977223899861,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 102,
        "expectedLow": 30.914568275972094,
        "expectedHigh": 103.34685948837463,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 80,
        "expectedLow": 40.890423644386765,
        "expectedHigh": 122.51228088475321,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 106,
        "expectedLow": 45.963540707722885,
        "expectedHigh": 116.07388808303098,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 121,
        "expectedLow": 44.39941360272861,
        "expectedHigh": 115.19351259031299,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 123,
        "expectedLow": 51.16792116789758,
        "expectedHigh": 152.54193221680003,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 159,
        "expectedLow": 67.57842222801807,
        "expectedHigh": 182.344774950627,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 101,
        "expectedLow": 64.522722135456,
        "expectedHigh": 164.78822596967964,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 123,
        "expectedLow": 68.0840135466091,
        "expectedHigh": 174.39069474343304,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "DTZ (Oxygenator, Cardiopulmonary Bypass) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-0487-2026). 2 first-time filers in the last 12 months, Lifemotion Medical Technology Co., Ltd. and Spectrum Medical S.R.L (K253838, K240934). The code is crowded, scoring 69 of 100 — 59 companies hold a clearance here and 4 arrived in the last 12 months (DTZ:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-0487-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "2 first-time filers in the last 12 months, Lifemotion Medical Technology Co., Ltd. and Spectrum Medical S.R.L.",
        "recordIds": [
          "K253838",
          "K240934"
        ],
        "severity": 42
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 69 of 100 — 59 companies hold a clearance here and 4 arrived in the last 12 months",
        "recordIds": [
          "DTZ: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%3ADTZ"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADTZ"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADTZ"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADTZ"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADTZ"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADTZ"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADTZ"
    }
  ],
  "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": "2026-08-11T13:51:45.683Z"
}