{
  "code": "DQO",
  "deviceName": "Catheter, Intravascular, Diagnostic",
  "deviceClass": "II",
  "regulationNumber": "870.1200",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 501,
    "last12Months": 3
  },
  "adverseEvents": {
    "total": 1642,
    "last12Months": 503
  },
  "reviewDays": {
    "median": 88,
    "sampleSize": 501
  },
  "recalls": {
    "total": 284,
    "recent": [
      {
        "resNumber": "Z-1934-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Cook Incorporated",
        "firmAsPublished": "Cook Incorporated",
        "reason": "Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.",
        "initiated": "2026-04-02"
      },
      {
        "resNumber": "Z-1935-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Cook Incorporated",
        "firmAsPublished": "Cook Incorporated",
        "reason": "Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.",
        "initiated": "2026-04-02"
      },
      {
        "resNumber": "Z-1936-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Cook Incorporated",
        "firmAsPublished": "Cook Incorporated",
        "reason": "Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.",
        "initiated": "2026-04-02"
      },
      {
        "resNumber": "Z-1823-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Gentuity, LLC",
        "firmAsPublished": "Gentuity, LLC",
        "reason": "The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.",
        "initiated": "2026-03-23"
      },
      {
        "resNumber": "Z-1778-2026",
        "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"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261455",
      "deviceName": "Arterial Pressure Monitoring Set/Tray",
      "applicant": "Spectrum Vascular",
      "company": "Spectrum Vascular",
      "decisionDate": "2026-06-26",
      "dateReceived": "2026-05-01"
    },
    {
      "kNumber": "K252702",
      "deviceName": "Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N",
      "applicant": "Bioptimal International Pte. , Ltd.",
      "company": "Bioptimal International Pte. , Ltd.",
      "decisionDate": "2026-05-28",
      "dateReceived": "2025-08-27"
    },
    {
      "kNumber": "K254278",
      "deviceName": "Arterial Pressure Monitoring Set/Tray",
      "applicant": "Spectrum Vascular",
      "company": "Spectrum Vascular",
      "decisionDate": "2026-03-25",
      "dateReceived": "2025-12-30"
    },
    {
      "kNumber": "K250751",
      "deviceName": "DualView Catheter",
      "applicant": "Terumo Corporation",
      "company": "Terumo Corporation",
      "decisionDate": "2025-07-17",
      "dateReceived": "2025-03-12"
    },
    {
      "kNumber": "K242966",
      "deviceName": "Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter",
      "applicant": "Gentuity, LLC",
      "company": "Gentuity, LLC",
      "decisionDate": "2025-01-31",
      "dateReceived": "2024-09-26"
    },
    {
      "kNumber": "K242420",
      "deviceName": "pNOVUS 21 Microcatheter",
      "applicant": "Phenox, Ltd.",
      "company": "Phenox Limited",
      "decisionDate": "2024-11-12",
      "dateReceived": "2024-08-15"
    },
    {
      "kNumber": "K233268",
      "deviceName": "Impress Angiographic Catheter",
      "applicant": "Merit Medical Systems, Inc.",
      "company": "Merit Medical Systems, Inc.",
      "decisionDate": "2024-05-22",
      "dateReceived": "2023-09-29"
    },
    {
      "kNumber": "K233975",
      "deviceName": "Zoom 6F Insert Catheters",
      "applicant": "Imperative Care, Inc.",
      "company": "IMPERATIVE CARE INC",
      "decisionDate": "2024-04-02",
      "dateReceived": "2023-12-15"
    },
    {
      "kNumber": "K232536",
      "deviceName": "Soldier Microcatheter",
      "applicant": "Embolx, Inc.",
      "company": "Embolx, Inc.",
      "decisionDate": "2024-02-23",
      "dateReceived": "2023-08-21"
    },
    {
      "kNumber": "K232573",
      "deviceName": "INFINITI™ Ambi Angiographic Catheter",
      "applicant": "Cordis US Corp",
      "company": "Cordis US Corp",
      "decisionDate": "2023-11-21",
      "dateReceived": "2023-08-25"
    }
  ],
  "topApplicants": [
    {
      "name": "Cordis Corp.",
      "count": 28
    },
    {
      "name": "Boston Scientific Corp",
      "count": 19
    },
    {
      "name": "C.R. Bard, Inc.",
      "count": 16
    },
    {
      "name": "Scimed Life Systems, Inc.",
      "count": 16
    },
    {
      "name": "AngioDynamics, Inc.",
      "count": 11
    }
  ],
  "topCompanies": [
    {
      "name": "Cordis Corporation",
      "count": 29,
      "spellings": 2
    },
    {
      "name": "Boston Scientific Corporation",
      "count": 20,
      "spellings": 2
    },
    {
      "name": "C.R. Bard, Inc.",
      "count": 16,
      "spellings": 1
    },
    {
      "name": "Scimed Life Systems, Inc.",
      "count": 16,
      "spellings": 1
    },
    {
      "name": "Cook Incorporated",
      "count": 15,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Bioptimal International Pte. , Ltd.",
      "since": "2026-05-28",
      "kNumber": "K252702"
    },
    {
      "name": "Spectrum Vascular",
      "since": "2026-03-25",
      "kNumber": "K254278"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 27,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 37,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 22,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 40,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 30,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 33,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 34,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 42,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 46,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 26,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 32,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 43,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 35,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 56,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 40,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 44,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 35,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 40,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 72,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 29,
        "expectedLow": 25.28366198987107,
        "expectedHigh": 64.96299514106978,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 35,
        "expectedLow": 17.02426168531647,
        "expectedHigh": 53.267198305265445,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 49,
        "expectedLow": 19.102273647913094,
        "expectedHigh": 58.94107966408999,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 43,
        "expectedLow": 23.454975967473853,
        "expectedHigh": 63.56978109170674,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 65,
        "expectedLow": 22.52494693106403,
        "expectedHigh": 59.00461987360976,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 51,
        "expectedLow": 25.334833977847037,
        "expectedHigh": 74.16769329337649,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 66,
        "expectedLow": 40.64643206193968,
        "expectedHigh": 117.50950241224774,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 51,
        "expectedLow": 27.667708392703723,
        "expectedHigh": 85.49019994611335,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 51,
        "expectedLow": 28.229377619705115,
        "expectedHigh": 87.50707504375926,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 68,
        "expectedLow": 25.871317773721238,
        "expectedHigh": 84.65578461299944,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 88,
        "expectedLow": 28.299736287328496,
        "expectedHigh": 78.40284906842751,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 47,
        "expectedLow": 36.32620252093595,
        "expectedHigh": 105.87469870488955,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 102,
        "expectedLow": 33.62452189012656,
        "expectedHigh": 112.39153926555782,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 43,
        "expectedLow": 35.84705305045299,
        "expectedHigh": 102.75344843916929,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 66,
        "expectedLow": 29.91353046899303,
        "expectedHigh": 105.09813464409284,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "DQO (Catheter, Intravascular, Diagnostic) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class I, Class II) (Z-1934-2026, Z-1935-2026, Z-1936-2026, Z-1823-2026, Z-1778-2026). 2 first-time filers in the last 12 months, Bioptimal International Pte. , Ltd. and Spectrum Vascular (K252702, K254278). The code is crowded, scoring 81 of 100 — 194 companies hold a clearance here and 3 arrived in the last 12 months (DQO:crowding).",
    "severity": 85,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class I, Class II)",
        "recordIds": [
          "Z-1934-2026",
          "Z-1935-2026",
          "Z-1936-2026",
          "Z-1823-2026",
          "Z-1778-2026"
        ],
        "severity": 85
      },
      {
        "kind": "new_entrant",
        "detail": "2 first-time filers in the last 12 months, Bioptimal International Pte. , Ltd. and Spectrum Vascular",
        "recordIds": [
          "K252702",
          "K254278"
        ],
        "severity": 42
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 81 of 100 — 194 companies hold a clearance here and 3 arrived in the last 12 months",
        "recordIds": [
          "DQO: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%3ADQO"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADQO"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADQO"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADQO"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADQO"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADQO"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADQO"
    }
  ],
  "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": "2026-08-11T13:51:45.678Z"
}