{
  "code": "DXC",
  "deviceName": "Clamp, Vascular",
  "deviceClass": "II",
  "regulationNumber": "870.4450",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 205,
    "last12Months": 6
  },
  "adverseEvents": {
    "total": 1511,
    "last12Months": 270
  },
  "reviewDays": {
    "median": 94,
    "sampleSize": 205
  },
  "recalls": {
    "total": 26,
    "recent": [
      {
        "resNumber": "Z-2586-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Maquet Cardiovascular, LLC",
        "firmAsPublished": "Maquet Cardiovascular, LLC",
        "reason": "Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.",
        "initiated": "2025-08-15"
      },
      {
        "resNumber": "Z-2587-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Maquet Cardiovascular, LLC",
        "firmAsPublished": "Maquet Cardiovascular, LLC",
        "reason": "Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.",
        "initiated": "2025-08-15"
      },
      {
        "resNumber": "Z-2588-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Maquet Cardiovascular, LLC",
        "firmAsPublished": "Maquet Cardiovascular, LLC",
        "reason": "Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.",
        "initiated": "2025-08-15"
      },
      {
        "resNumber": "Z-2637-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "North American Rescue LLC.",
        "firmAsPublished": "North American Rescue LLC.",
        "reason": "Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.",
        "initiated": "2025-07-01"
      },
      {
        "resNumber": "Z-1522-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Baxter Healthcare Corporation",
        "firmAsPublished": "Baxter Healthcare Corporation",
        "reason": "The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).",
        "initiated": "2024-02-22"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K262086",
      "deviceName": "PreludeSYNC™ Radial Compression Device",
      "applicant": "Merit Medical Systems, Inc.",
      "company": "Merit Medical Systems, Inc.",
      "decisionDate": "2026-07-22",
      "dateReceived": "2026-06-22"
    },
    {
      "kNumber": "K260105",
      "deviceName": "Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts",
      "applicant": "Edwards Lifesciences",
      "company": "Edwards Lifesciences, LLC",
      "decisionDate": "2026-06-05",
      "dateReceived": "2026-01-13"
    },
    {
      "kNumber": "K252772",
      "deviceName": "Arc Adjustable Radial Cuff Compression Device",
      "applicant": "Tz Medical, Inc.",
      "company": "TZ Medical, Inc.",
      "decisionDate": "2026-05-22",
      "dateReceived": "2025-09-02"
    },
    {
      "kNumber": "K254060",
      "deviceName": "Life Saving Tourniquet",
      "applicant": "TW Medical",
      "company": "TW Medical",
      "decisionDate": "2026-04-03",
      "dateReceived": "2025-12-17"
    },
    {
      "kNumber": "K243627",
      "deviceName": "Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)",
      "applicant": "Arc Trauma, LLC",
      "company": "Arc Trauma, LLC",
      "decisionDate": "2025-12-31",
      "dateReceived": "2024-11-25"
    },
    {
      "kNumber": "K253070",
      "deviceName": "Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)",
      "applicant": "Medline Industries, LP",
      "company": "Medline Industries, LP",
      "decisionDate": "2025-11-20",
      "dateReceived": "2025-09-23"
    },
    {
      "kNumber": "K232577",
      "deviceName": "Radial Compression Device",
      "applicant": "Ningbo Dizegens Medical Science Co.,Ltd",
      "company": "Ningbo Dizegens Medical Science Co.,Ltd",
      "decisionDate": "2024-01-18",
      "dateReceived": "2023-08-25"
    },
    {
      "kNumber": "K230281",
      "deviceName": "PICOCLAMP",
      "applicant": "Kono Seisakusho Co., Ltd.",
      "company": "Kono Seisakusho Co., Ltd.",
      "decisionDate": "2023-10-23",
      "dateReceived": "2023-02-01"
    },
    {
      "kNumber": "K221661",
      "deviceName": "Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)",
      "applicant": "Compression Works, Inc.",
      "company": "Compression Works, Inc.",
      "decisionDate": "2023-03-03",
      "dateReceived": "2022-06-08"
    },
    {
      "kNumber": "K230248",
      "deviceName": "VIOLA",
      "applicant": "Vascular Graft Solutions, Ltd.",
      "company": "Vascular Graft Solutions, Ltd.",
      "decisionDate": "2023-02-28",
      "dateReceived": "2023-01-30"
    }
  ],
  "topApplicants": [
    {
      "name": "Radi Medical Systems AB",
      "count": 8
    },
    {
      "name": "Cardiva Medical, Inc.",
      "count": 7
    },
    {
      "name": "Advanced Vascular Dynamics",
      "count": 6
    },
    {
      "name": "Novare Surgical Systems, Inc.",
      "count": 6
    },
    {
      "name": "Applied Vascular Devices, Inc.",
      "count": 5
    }
  ],
  "topCompanies": [
    {
      "name": "Radi Medical Systems AB",
      "count": 8,
      "spellings": 1
    },
    {
      "name": "Cardiva Medical, Inc.",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "Advanced Vascular Dynamics",
      "count": 6,
      "spellings": 1
    },
    {
      "name": "Novare Surgical Systems, Inc.",
      "count": 6,
      "spellings": 1
    },
    {
      "name": "Applied Vascular Devices, Inc.",
      "count": 5,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "TW Medical",
      "since": "2026-04-03",
      "kNumber": "K254060"
    },
    {
      "name": "Arc Trauma, LLC",
      "since": "2025-12-31",
      "kNumber": "K243627"
    },
    {
      "name": "Medline Industries, LP",
      "since": "2025-11-20",
      "kNumber": "K253070"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 37,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 40,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 30,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 102,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 194,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 73,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 44,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 26,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 24,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 21,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 37,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 28,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 45,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 40,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 41,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 17,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 28,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 32,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 33,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 29,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 18,
        "expectedLow": 11.0577855403583,
        "expectedHigh": 44.80747832323755,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 34,
        "expectedLow": 6.168735547851573,
        "expectedHigh": 37.23771803477775,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 29,
        "expectedLow": 11.28670793170516,
        "expectedHigh": 45.992852793590025,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 29,
        "expectedLow": 12.17654087700662,
        "expectedHigh": 46.998874782125434,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 47,
        "expectedLow": 11.437674635356931,
        "expectedHigh": 44.08626964477639,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 46,
        "expectedLow": 15.569325016761038,
        "expectedHigh": 53.95724822440305,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 76,
        "expectedLow": 27.833393672322728,
        "expectedHigh": 91.82595012778118,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 28,
        "expectedLow": 21.536054254846498,
        "expectedHigh": 75.55719151586106,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 33,
        "expectedLow": 18.70413247490099,
        "expectedHigh": 70.86484960033786,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 27,
        "expectedLow": 15.221145217510724,
        "expectedHigh": 66.79211136029944,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 22,
        "expectedLow": 9.184348607876506,
        "expectedHigh": 57.24264593225517,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 45,
        "expectedLow": 4.958963829173432,
        "expectedHigh": 61.041778592498694,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 19,
        "expectedLow": 9.899093472705484,
        "expectedHigh": 74.25289779815219,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 18,
        "expectedLow": 1.501257162657639,
        "expectedHigh": 58.66317550797563,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 84,
        "expectedLow": 0,
        "expectedHigh": 62.07570321088193,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "DXC (Clamp, Vascular) has four findings, most consequential first. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2586-2025, Z-2587-2025, Z-2588-2025). Adverse events reported in 2026-03 ran high — 84 reports against an expected 0 to 62 (DXC:MAUDE:2026-03). 3 first-time filers in the last 12 months, including TW Medical and Arc Trauma, LLC (K254060, K243627, K253070). The code is crowded, scoring 83 of 100 — 123 companies hold a clearance here and 6 arrived in the last 12 months (DXC:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "3 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2586-2025",
          "Z-2587-2025",
          "Z-2588-2025"
        ],
        "severity": 75
      },
      {
        "kind": "spike",
        "detail": "adverse events reported in 2026-03 ran high — 84 reports against an expected 0 to 62",
        "recordIds": [
          "DXC:MAUDE:2026-03"
        ],
        "severity": 63
      },
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including TW Medical and Arc Trauma, LLC",
        "recordIds": [
          "K254060",
          "K243627",
          "K253070"
        ],
        "severity": 43
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 83 of 100 — 123 companies hold a clearance here and 6 arrived in the last 12 months",
        "recordIds": [
          "DXC: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%3ADXC"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADXC"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADXC"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADXC"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADXC"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADXC"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADXC"
    }
  ],
  "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": "2026-08-11T13:51:45.685Z"
}