{
  "code": "DYB",
  "deviceName": "Introducer, Catheter",
  "deviceClass": "II",
  "regulationNumber": "870.1340",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 705,
    "last12Months": 24
  },
  "adverseEvents": {
    "total": 12815,
    "last12Months": 3634
  },
  "reviewDays": {
    "median": 87,
    "sampleSize": 705
  },
  "recalls": {
    "total": 388,
    "recent": [
      {
        "resNumber": "Z-2681-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Abiomed, Inc.",
        "firmAsPublished": "Abiomed, Inc.",
        "reason": "A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.",
        "initiated": "2026-06-11"
      },
      {
        "resNumber": "Z-2682-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Abiomed, Inc.",
        "firmAsPublished": "Abiomed, Inc.",
        "reason": "A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.",
        "initiated": "2026-06-11"
      },
      {
        "resNumber": "Z-2683-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Abiomed, Inc.",
        "firmAsPublished": "Abiomed, Inc.",
        "reason": "A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.",
        "initiated": "2026-06-11"
      },
      {
        "resNumber": "Z-2684-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Abiomed, Inc.",
        "firmAsPublished": "Abiomed, Inc.",
        "reason": "A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.",
        "initiated": "2026-06-11"
      },
      {
        "resNumber": "Z-2685-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Abiomed, Inc.",
        "firmAsPublished": "Abiomed, Inc.",
        "reason": "A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.",
        "initiated": "2026-06-11"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261529",
      "deviceName": "Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)",
      "applicant": "Hartman Medical Group, LLC",
      "company": "Hartman Medical Group, LLC",
      "decisionDate": "2026-07-06",
      "dateReceived": "2026-05-08"
    },
    {
      "kNumber": "K261242",
      "deviceName": "SimplGuide",
      "applicant": "Pendracare",
      "company": "Pendracare",
      "decisionDate": "2026-06-25",
      "dateReceived": "2026-04-15"
    },
    {
      "kNumber": "K261950",
      "deviceName": "Health Line Tearaway Introducer",
      "applicant": "Health Line International Corporation",
      "company": "Health Line International Corporation",
      "decisionDate": "2026-06-22",
      "dateReceived": "2026-06-10"
    },
    {
      "kNumber": "K261492",
      "deviceName": "FieldFlex Steerable Sheath",
      "applicant": "CenterPoint Systems, LLC",
      "company": "CenterPoint Systems, LLC",
      "decisionDate": "2026-06-05",
      "dateReceived": "2026-05-06"
    },
    {
      "kNumber": "K260606",
      "deviceName": "Echo Large Bore Introducer Sheath",
      "applicant": "Echo Medical, LLC",
      "company": "Echo Medical, LLC",
      "decisionDate": "2026-04-29",
      "dateReceived": "2026-02-24"
    },
    {
      "kNumber": "K254248",
      "deviceName": "Introducer Sheath Set",
      "applicant": "Cardiocycle Medical(Suzhou) Co., Ltd.",
      "company": "Cardiocycle Medical(Suzhou) Co., Ltd.",
      "decisionDate": "2026-04-23",
      "dateReceived": "2025-12-29"
    },
    {
      "kNumber": "K254279",
      "deviceName": "Edwards eSheath+ introducer set",
      "applicant": "Edwards Lifesciences",
      "company": "Edwards Lifesciences, LLC",
      "decisionDate": "2026-04-17",
      "dateReceived": "2025-12-30"
    },
    {
      "kNumber": "K260091",
      "deviceName": "Aventus Introducer Sheath",
      "applicant": "Inquis Medical",
      "company": "INQUIS MEDICAL, INC.",
      "decisionDate": "2026-04-13",
      "dateReceived": "2026-01-12"
    },
    {
      "kNumber": "K260839",
      "deviceName": "Protaryx Transseptal  Puncture Device (PTX2-001)",
      "applicant": "Protaryx Medical, Inc.",
      "company": "Protaryx Medical, Inc.",
      "decisionDate": "2026-04-10",
      "dateReceived": "2026-03-13"
    },
    {
      "kNumber": "K260942",
      "deviceName": "AuST Steerable Sheath",
      "applicant": "CenterPoint Systems, LLC",
      "company": "CenterPoint Systems, LLC",
      "decisionDate": "2026-04-07",
      "dateReceived": "2026-03-20"
    }
  ],
  "topApplicants": [
    {
      "name": "St Jude Medical",
      "count": 21
    },
    {
      "name": "Cordis Corp.",
      "count": 19
    },
    {
      "name": "Terumo Medical Corp.",
      "count": 19
    },
    {
      "name": "Daig Corp.",
      "count": 18
    },
    {
      "name": "Merit Medical Systems, Inc.",
      "count": 18
    }
  ],
  "topCompanies": [
    {
      "name": "Terumo Medical Corporation",
      "count": 27,
      "spellings": 2
    },
    {
      "name": "St. Jude Medical, Inc.",
      "count": 26,
      "spellings": 2
    },
    {
      "name": "Cordis Corporation",
      "count": 22,
      "spellings": 2
    },
    {
      "name": "Cook Incorporated",
      "count": 20,
      "spellings": 2
    },
    {
      "name": "Merit Medical Systems, Inc.",
      "count": 19,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Hartman Medical Group, LLC",
      "since": "2026-07-06",
      "kNumber": "K261529"
    },
    {
      "name": "Pendracare",
      "since": "2026-06-25",
      "kNumber": "K261242"
    },
    {
      "name": "Health Line International Corporation",
      "since": "2026-06-22",
      "kNumber": "K261950"
    },
    {
      "name": "Echo Medical, LLC",
      "since": "2026-04-29",
      "kNumber": "K260606"
    },
    {
      "name": "INQUIS MEDICAL, INC.",
      "since": "2026-04-13",
      "kNumber": "K260091"
    },
    {
      "name": "Protaryx Medical, Inc.",
      "since": "2026-04-10",
      "kNumber": "K260839"
    },
    {
      "name": "Zoll Respicardia, Inc.",
      "since": "2026-04-06",
      "kNumber": "K260459"
    },
    {
      "name": "VascuTech Medical, LLC",
      "since": "2026-02-09",
      "kNumber": "K254236"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 226,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 289,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 402,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 275,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 286,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 340,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 233,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 416,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 254,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 275,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 282,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 354,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 335,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 323,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 347,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 382,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 340,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 270,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 317,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 319,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 387,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 292,
        "expectedLow": 230.88391966216807,
        "expectedHigh": 386.35474364061224,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 251,
        "expectedLow": 200.3610219187921,
        "expectedHigh": 328.8481102652096,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 318,
        "expectedLow": 222.1402136032389,
        "expectedHigh": 363.0737576881507,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 310,
        "expectedLow": 242.588911765437,
        "expectedHigh": 377.53188510881444,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 358,
        "expectedLow": 229.96799207934808,
        "expectedHigh": 350.5648814076376,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 414,
        "expectedLow": 248.43253864098378,
        "expectedHigh": 397.23674210815506,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 348,
        "expectedLow": 403.7322448014809,
        "expectedHigh": 696.2089068939351,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 382,
        "expectedLow": 243.74876067686992,
        "expectedHigh": 494.8771264257563,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 385,
        "expectedLow": 259.12038879531866,
        "expectedHigh": 524.4240972841831,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 462,
        "expectedLow": 264.1442701128729,
        "expectedHigh": 511.00874580398414,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 398,
        "expectedLow": 256.25912117905824,
        "expectedHigh": 483.224271631035,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 545,
        "expectedLow": 294.00056092628876,
        "expectedHigh": 545.9604111926944,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 421,
        "expectedLow": 353.02157582049676,
        "expectedHigh": 700.5896632018128,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 468,
        "expectedLow": 272.9849453008491,
        "expectedHigh": 564.4614501743322,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 678,
        "expectedLow": 317.5529398082387,
        "expectedHigh": 634.3276503183921,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "DYB (Introducer, Catheter) has five findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class I) (Z-2681-2026, Z-2682-2026, Z-2683-2026, Z-2684-2026, Z-2685-2026). Adverse events reported in 2026-03 ran high — 678 reports against an expected 318 to 634 (DYB:MAUDE:2026-03). 13 first-time filers in the last 12 months, including Hartman Medical Group, LLC and Pendracare (K261529, K261242, K261950, K260606, K260091). Clearances are running 36% faster — a median 56 days over the last 12 months against 87 days all-time (elapsed calendar days, not FDA review days) (DYB:review_time:12m). The code is crowded, scoring 100 of 100 — 244 companies hold a clearance here and 24 arrived in the last 12 months (DYB:crowding).",
    "severity": 85,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class I)",
        "recordIds": [
          "Z-2681-2026",
          "Z-2682-2026",
          "Z-2683-2026",
          "Z-2684-2026",
          "Z-2685-2026"
        ],
        "severity": 85
      },
      {
        "kind": "spike",
        "detail": "adverse events reported in 2026-03 ran high — 678 reports against an expected 318 to 634",
        "recordIds": [
          "DYB:MAUDE:2026-03"
        ],
        "severity": 63
      },
      {
        "kind": "new_entrant",
        "detail": "13 first-time filers in the last 12 months, including Hartman Medical Group, LLC and Pendracare",
        "recordIds": [
          "K261529",
          "K261242",
          "K261950",
          "K260606",
          "K260091"
        ],
        "severity": 50
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 36% faster — a median 56 days over the last 12 months against 87 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "DYB:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 100 of 100 — 244 companies hold a clearance here and 24 arrived in the last 12 months",
        "recordIds": [
          "DYB: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%3ADYB"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADYB"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADYB"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADYB"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADYB"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADYB"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADYB"
    }
  ],
  "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": "2026-08-11T13:51:45.688Z"
}