{
  "code": "DQX",
  "deviceName": "Wire, Guide, Catheter",
  "deviceClass": "II",
  "regulationNumber": "870.1330",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 766,
    "last12Months": 13
  },
  "adverseEvents": {
    "total": 6388,
    "last12Months": 1423
  },
  "reviewDays": {
    "median": 89,
    "sampleSize": 766
  },
  "recalls": {
    "total": 257,
    "recent": [
      {
        "resNumber": "Z-2517-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Merit Medical Systems, Inc.",
        "firmAsPublished": "Merit Medical Systems, Inc.",
        "reason": "Due to unsealed portions of pouches.",
        "initiated": "2026-05-08"
      },
      {
        "resNumber": "Z-2397-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Arrow International, Inc., Division of Teleflex Medical Inc.",
        "firmAsPublished": "ARROW INTERNATIONAL, LLC",
        "reason": "Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.",
        "initiated": "2026-04-21"
      },
      {
        "resNumber": "Z-1775-2026",
        "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-1776-2026",
        "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-1777-2026",
        "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": "K253667",
      "deviceName": "Accoat Guide Wire",
      "applicant": "Sp Medical A/S",
      "company": "Sp Medical A/S",
      "decisionDate": "2026-07-14",
      "dateReceived": "2025-11-21"
    },
    {
      "kNumber": "K261640",
      "deviceName": "Merit MAK Nitinol/Gold-Tungsten Guide Wire",
      "applicant": "Merit Medical Ireland , Ltd.",
      "company": "Merit Medical Ireland , Ltd.",
      "decisionDate": "2026-07-13",
      "dateReceived": "2026-05-18"
    },
    {
      "kNumber": "K254137",
      "deviceName": "InQwire Amplatz Guide Wire",
      "applicant": "Merit Medical Ireland, Ltd.",
      "company": "Merit Medical Ireland , Ltd.",
      "decisionDate": "2026-05-22",
      "dateReceived": "2025-12-22"
    },
    {
      "kNumber": "K260544",
      "deviceName": "FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40",
      "applicant": "FMD Co., Ltd.",
      "company": "FMD. Co., Ltd.",
      "decisionDate": "2026-03-20",
      "dateReceived": "2026-02-18"
    },
    {
      "kNumber": "K253746",
      "deviceName": "Enroute 0.014'' Transcarotid Guidewire",
      "applicant": "Lake Region Medical",
      "company": "Lake Region Medical",
      "decisionDate": "2026-03-19",
      "dateReceived": "2025-11-25"
    },
    {
      "kNumber": "K253262",
      "deviceName": "EmeryGlide™ (EG18008901)",
      "applicant": "Nano4imaging GmbH",
      "company": "Nano4imaging GmbH",
      "decisionDate": "2026-03-06",
      "dateReceived": "2025-09-29"
    },
    {
      "kNumber": "K253847",
      "deviceName": "Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)",
      "applicant": "Merit Medical Ireland, Ltd.",
      "company": "Merit Medical Ireland , Ltd.",
      "decisionDate": "2026-01-31",
      "dateReceived": "2025-12-02"
    },
    {
      "kNumber": "K251385",
      "deviceName": "InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)",
      "applicant": "Merit Medical Ireland, Ltd.",
      "company": "Merit Medical Ireland , Ltd.",
      "decisionDate": "2026-01-21",
      "dateReceived": "2025-05-05"
    },
    {
      "kNumber": "K252674",
      "deviceName": "Solo Pace Fusion System (SOLOFUSE1)",
      "applicant": "Solo Pace, Inc.",
      "company": "Solo Pace, Inc.",
      "decisionDate": "2026-01-09",
      "dateReceived": "2025-08-25"
    },
    {
      "kNumber": "K251596",
      "deviceName": "Lunderquist Extra Stiff Wire Guide",
      "applicant": "William Cook Europe Aps",
      "company": "William Cook Europe Aps",
      "decisionDate": "2025-11-09",
      "dateReceived": "2025-05-27"
    }
  ],
  "topApplicants": [
    {
      "name": "Asahi Intecc Co., Ltd.",
      "count": 47
    },
    {
      "name": "Advanced Cardiovascular Systems, Inc.",
      "count": 45
    },
    {
      "name": "Lake Region Mfg., Inc.",
      "count": 31
    },
    {
      "name": "Scimed Life Systems, Inc.",
      "count": 30
    },
    {
      "name": "Cordis Corp.",
      "count": 25
    }
  ],
  "topCompanies": [
    {
      "name": "Asahi Intecc Co., Ltd.",
      "count": 47,
      "spellings": 1
    },
    {
      "name": "Advanced Cardiovascular Systems, Inc.",
      "count": 45,
      "spellings": 1
    },
    {
      "name": "Boston Scientific Corporation",
      "count": 34,
      "spellings": 4
    },
    {
      "name": "Lake Region Mfg., Inc.",
      "count": 31,
      "spellings": 1
    },
    {
      "name": "Scimed Life Systems, Inc.",
      "count": 30,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Sp Medical A/S",
      "since": "2026-07-14",
      "kNumber": "K253667"
    },
    {
      "name": "Solo Pace, Inc.",
      "since": "2026-01-09",
      "kNumber": "K252674"
    },
    {
      "name": "SUREAX MEDICAL, CORPORATION",
      "since": "2025-10-17",
      "kNumber": "K250203"
    },
    {
      "name": "Merit Medical Ireland , Ltd.",
      "since": "2025-08-29",
      "kNumber": "K251181"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 105,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 149,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 210,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 122,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 144,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 149,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 134,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 327,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 118,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 177,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 194,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 164,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 152,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 266,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 131,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 166,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 212,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 150,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 233,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 166,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 199,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 137,
        "expectedLow": 107.75597831789615,
        "expectedHigh": 234.44164843739495,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 139,
        "expectedLow": 82.26224947243847,
        "expectedHigh": 198.4504984578196,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 146,
        "expectedLow": 92.37055911215928,
        "expectedHigh": 220.15149675861238,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 219,
        "expectedLow": 91.32332912675572,
        "expectedHigh": 225.00950310359863,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 170,
        "expectedLow": 98.5875819454228,
        "expectedHigh": 234.78809870419994,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 171,
        "expectedLow": 119.94442477715987,
        "expectedHigh": 224.70385150773012,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 197,
        "expectedLow": 192.35110506283567,
        "expectedHigh": 348.6406980825336,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 169,
        "expectedLow": 124.95800520161268,
        "expectedHigh": 251.94139047123934,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 201,
        "expectedLow": 124.96836201046227,
        "expectedHigh": 257.7114632244296,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 175,
        "expectedLow": 130.70986470706856,
        "expectedHigh": 257.3023258985483,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 217,
        "expectedLow": 116.01265825789807,
        "expectedHigh": 221.95768702724197,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 180,
        "expectedLow": 139.88608137983525,
        "expectedHigh": 267.3802757361375,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 159,
        "expectedLow": 152.32536367904035,
        "expectedHigh": 299.6349398570774,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 167,
        "expectedLow": 105.6196548615842,
        "expectedHigh": 243.44952847447536,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 197,
        "expectedLow": 111.74791849550553,
        "expectedHigh": 265.62961489378,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "DQX (Wire, Guide, Catheter) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class I, Class II) (Z-2517-2026, Z-2397-2026, Z-1775-2026, Z-1776-2026, Z-1777-2026). 4 first-time filers in the last 12 months, including Sp Medical A/S and Solo Pace, Inc (K253667, K252674, K250203, K251181). Clearances are running 70% slower — a median 151 days over the last 12 months against 89 days all-time (elapsed calendar days, not FDA review days) (DQX:review_time:12m). The code is crowded, scoring 95 of 100 — 195 companies hold a clearance here and 13 arrived in the last 12 months (DQX: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-2517-2026",
          "Z-2397-2026",
          "Z-1775-2026",
          "Z-1776-2026",
          "Z-1777-2026"
        ],
        "severity": 85
      },
      {
        "kind": "new_entrant",
        "detail": "4 first-time filers in the last 12 months, including Sp Medical A/S and Solo Pace, Inc.",
        "recordIds": [
          "K253667",
          "K252674",
          "K250203",
          "K251181"
        ],
        "severity": 44
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 70% slower — a median 151 days over the last 12 months against 89 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "DQX:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 95 of 100 — 195 companies hold a clearance here and 13 arrived in the last 12 months",
        "recordIds": [
          "DQX: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%3ADQX"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADQX"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADQX"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADQX"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADQX"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADQX"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADQX"
    }
  ],
  "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"
}