{
  "code": "DWF",
  "deviceName": "Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass",
  "deviceClass": "II",
  "regulationNumber": "870.4210",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 401,
    "last12Months": 7
  },
  "adverseEvents": {
    "total": 2099,
    "last12Months": 771
  },
  "reviewDays": {
    "median": 83,
    "sampleSize": 401
  },
  "recalls": {
    "total": 560,
    "recent": [
      {
        "resNumber": "Z-2806-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Medtronic Perfusion Systems",
        "firmAsPublished": "Medtronic Perfusion Systems",
        "reason": "Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.",
        "initiated": "2026-06-24"
      },
      {
        "resNumber": "Z-2807-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Medtronic Perfusion Systems",
        "firmAsPublished": "Medtronic Perfusion Systems",
        "reason": "Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.",
        "initiated": "2026-06-24"
      },
      {
        "resNumber": "Z-2808-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Medtronic Perfusion Systems",
        "firmAsPublished": "Medtronic Perfusion Systems",
        "reason": "Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.",
        "initiated": "2026-06-24"
      },
      {
        "resNumber": "Z-2809-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Medtronic Perfusion Systems",
        "firmAsPublished": "Medtronic Perfusion Systems",
        "reason": "Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.",
        "initiated": "2026-06-24"
      },
      {
        "resNumber": "Z-2810-2026",
        "status": "Open, Classified",
        "recallClass": null,
        "firm": "Medtronic Perfusion Systems",
        "firmAsPublished": "Medtronic Perfusion Systems",
        "reason": "Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.",
        "initiated": "2026-06-24"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260195",
      "deviceName": "Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae",
      "applicant": "Medtronic, Inc.",
      "company": "Medtronic, Inc.",
      "decisionDate": "2026-04-23",
      "dateReceived": "2026-01-22"
    },
    {
      "kNumber": "K250937",
      "deviceName": "Venous Return Cannulae",
      "applicant": "LivaNova USA, Inc.",
      "company": "LivaNova USA, Inc.",
      "decisionDate": "2026-03-11",
      "dateReceived": "2025-03-28"
    },
    {
      "kNumber": "K260043",
      "deviceName": "Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)",
      "applicant": "Smart Reactors",
      "company": "Smart Reactors",
      "decisionDate": "2026-02-23",
      "dateReceived": "2026-01-07"
    },
    {
      "kNumber": "K253203",
      "deviceName": "Retrograde Coronary Sinus Perfusion Cannulae",
      "applicant": "Medtronic, Inc.",
      "company": "Medtronic, Inc.",
      "decisionDate": "2026-02-19",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K253671",
      "deviceName": "Dual Stage Venous Cannulae",
      "applicant": "Sorin Group Italia S.R.L.",
      "company": "Sorin Group Italia S.r.l.",
      "decisionDate": "2026-01-30",
      "dateReceived": "2025-11-21"
    },
    {
      "kNumber": "K253998",
      "deviceName": "Clearview Intracoronary Shunts",
      "applicant": "Medtronic, Inc.",
      "company": "Medtronic, Inc.",
      "decisionDate": "2026-01-20",
      "dateReceived": "2025-12-12"
    },
    {
      "kNumber": "K253106",
      "deviceName": "AngioVac Cannula",
      "applicant": "AngioDynamics, Inc.",
      "company": "Angiodynamics",
      "decisionDate": "2025-10-24",
      "dateReceived": "2025-09-24"
    },
    {
      "kNumber": "K250283",
      "deviceName": "RAP Femoral Venous Cannulae",
      "applicant": "LivaNova USA, Inc.",
      "company": "LivaNova USA, Inc.",
      "decisionDate": "2025-07-10",
      "dateReceived": "2025-01-31"
    },
    {
      "kNumber": "K250610",
      "deviceName": "Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)",
      "applicant": "Sorin Group Italia S.R.L.",
      "company": "Sorin Group Italia S.r.l.",
      "decisionDate": "2025-06-27",
      "dateReceived": "2025-02-28"
    },
    {
      "kNumber": "K251258",
      "deviceName": "MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula",
      "applicant": "Medtronic, Inc.",
      "company": "Medtronic, Inc.",
      "decisionDate": "2025-06-20",
      "dateReceived": "2025-04-23"
    }
  ],
  "topApplicants": [
    {
      "name": "Medtronic, Inc.",
      "count": 31
    },
    {
      "name": "Dlp, Inc.",
      "count": 22
    },
    {
      "name": "3M Health Care, Sarns",
      "count": 21
    },
    {
      "name": "Shiley, Inc.",
      "count": 21
    },
    {
      "name": "Edwards Lifesciences, LLC",
      "count": 18
    }
  ],
  "topCompanies": [
    {
      "name": "Medtronic, Inc.",
      "count": 31,
      "spellings": 1
    },
    {
      "name": "Dlp, Inc.",
      "count": 22,
      "spellings": 1
    },
    {
      "name": "3M Health Care, Sarns",
      "count": 21,
      "spellings": 1
    },
    {
      "name": "Shiley, Inc.",
      "count": 21,
      "spellings": 1
    },
    {
      "name": "Edwards Lifesciences, LLC",
      "count": 19,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Smart Reactors",
      "since": "2026-02-23",
      "kNumber": "K260043"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 24,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 24,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 26,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 76,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 67,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 69,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 23,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 29,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 24,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 33,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 33,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 23,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 46,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 33,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 32,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 48,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 39,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 50,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 26,
        "expectedLow": 20.565909786339823,
        "expectedHigh": 54.03331936124257,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 191,
        "expectedLow": 16.159978688389135,
        "expectedHigh": 43.01355275684782,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 65,
        "expectedLow": 0,
        "expectedHigh": 193.3471696928092,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 83,
        "expectedLow": 0,
        "expectedHigh": 192.10888210878932,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 59,
        "expectedLow": 0,
        "expectedHigh": 180.65082392250852,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 67,
        "expectedLow": 0,
        "expectedHigh": 180.14959045689025,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 52,
        "expectedLow": 0,
        "expectedHigh": 276.5932620162465,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 60,
        "expectedLow": 0,
        "expectedHigh": 195.36204801714797,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 151,
        "expectedLow": 0,
        "expectedHigh": 199.65285888320597,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 65,
        "expectedLow": 0,
        "expectedHigh": 225.6266861823142,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 84,
        "expectedLow": 0,
        "expectedHigh": 193.9495173341876,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 81,
        "expectedLow": 0,
        "expectedHigh": 214.16518239134155,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 148,
        "expectedLow": 0,
        "expectedHigh": 241.93468479272065,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 116,
        "expectedLow": 0,
        "expectedHigh": 215.08306794778775,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 76,
        "expectedLow": 46.57242098863966,
        "expectedHigh": 176.71819156035,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Z-2806-2026, Z-2807-2026, Z-2808-2026, Z-2809-2026, Z-2810-2026). 1 first-time filer in the last 12 months, Smart Reactors (K260043). The code is crowded, scoring 76 of 100 — 117 companies hold a clearance here and 7 arrived in the last 12 months (DWF:crowding).",
    "severity": 70,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated",
        "recordIds": [
          "Z-2806-2026",
          "Z-2807-2026",
          "Z-2808-2026",
          "Z-2809-2026",
          "Z-2810-2026"
        ],
        "severity": 70
      },
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Smart Reactors",
        "recordIds": [
          "K260043"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 76 of 100 — 117 companies hold a clearance here and 7 arrived in the last 12 months",
        "recordIds": [
          "DWF: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%3ADWF"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADWF"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADWF"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADWF"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADWF"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADWF"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADWF"
    }
  ],
  "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": "2026-08-11T13:51:45.684Z"
}