{
  "code": "DXT",
  "deviceName": "Injector And Syringe, Angiographic",
  "deviceClass": "II",
  "regulationNumber": "870.1650",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 210,
    "last12Months": 7
  },
  "adverseEvents": {
    "total": 377,
    "last12Months": 119
  },
  "reviewDays": {
    "median": 98,
    "sampleSize": 210
  },
  "recalls": {
    "total": 69,
    "recent": [
      {
        "resNumber": "Z-2296-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Bayer Medical Care, Inc.",
        "firmAsPublished": "Bayer Medical Care, Inc.",
        "reason": "Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.",
        "initiated": "2026-04-24"
      },
      {
        "resNumber": "Z-1712-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Medline Industries, LP",
        "firmAsPublished": "Medline Industries, LP",
        "reason": "Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.",
        "initiated": "2026-02-27"
      },
      {
        "resNumber": "Z-1713-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Medline Industries, LP",
        "firmAsPublished": "Medline Industries, LP",
        "reason": "Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.",
        "initiated": "2026-02-27"
      },
      {
        "resNumber": "Z-1830-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medline Industries, LP",
        "firmAsPublished": "Medline Industries, LP",
        "reason": "The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.",
        "initiated": "2026-02-25"
      },
      {
        "resNumber": "Z-1831-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Medline Industries, LP",
        "firmAsPublished": "Medline Industries, LP",
        "reason": "The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.",
        "initiated": "2026-02-25"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K252652",
      "deviceName": "Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr",
      "applicant": "Fortis Biosolutions Company Limited",
      "company": "Fortis Biosolutions Company Limited",
      "decisionDate": "2026-05-14",
      "dateReceived": "2025-08-22"
    },
    {
      "kNumber": "K252653",
      "deviceName": "ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable",
      "applicant": "Acist Medical Systems, Inc.",
      "company": "Acist Medical Systems",
      "decisionDate": "2026-05-13",
      "dateReceived": "2025-08-22"
    },
    {
      "kNumber": "K252638",
      "deviceName": "VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)",
      "applicant": "Acist Medical Systems, Inc.",
      "company": "Acist Medical Systems",
      "decisionDate": "2026-05-13",
      "dateReceived": "2025-08-20"
    },
    {
      "kNumber": "K253048",
      "deviceName": "High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube",
      "applicant": "Shenzhen Maiwei Biotech Co., Ltd.",
      "company": "Shenzhen Maiwei Biotech Co., Ltd.",
      "decisionDate": "2026-04-16",
      "dateReceived": "2025-09-22"
    },
    {
      "kNumber": "K251788",
      "deviceName": "Extension tube",
      "applicant": "Zhuhai DR Medical Instruments Co., Ltd.",
      "company": "Zhuhai DR Medical Instruments Co., Ltd.",
      "decisionDate": "2026-03-05",
      "dateReceived": "2025-06-11"
    },
    {
      "kNumber": "K252891",
      "deviceName": "MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)",
      "applicant": "Bayer Medical Care, Inc.",
      "company": "Bayer Medical Care, Inc.",
      "decisionDate": "2026-02-13",
      "dateReceived": "2025-09-11"
    },
    {
      "kNumber": "K244038",
      "deviceName": "High Pressure Tubing",
      "applicant": "Shandong Int Medical Instruments Co., Ltd.",
      "company": "Shandong Int Medical Instruments Co., Ltd.",
      "decisionDate": "2025-09-05",
      "dateReceived": "2024-12-30"
    },
    {
      "kNumber": "K242143",
      "deviceName": "Angiography Injector",
      "applicant": "Shandong Int Medical Instruments Co., Ltd.",
      "company": "Shandong Int Medical Instruments Co., Ltd.",
      "decisionDate": "2024-12-23",
      "dateReceived": "2024-07-22"
    },
    {
      "kNumber": "K242212",
      "deviceName": "Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)",
      "applicant": "Nemoto Kyorindo Co., Ltd.",
      "company": "Nemoto Kyorindo Co., Ltd.",
      "decisionDate": "2024-08-27",
      "dateReceived": "2024-07-29"
    },
    {
      "kNumber": "K241109",
      "deviceName": "Single-use Sterile High-pressure Angiographic Syringes and Accessories",
      "applicant": "Shenzhen Boon Medical Supply Co., Ltd.",
      "company": "Shenzhen Boon Medical Supply Co., Ltd.",
      "decisionDate": "2024-08-22",
      "dateReceived": "2024-04-22"
    }
  ],
  "topApplicants": [
    {
      "name": "Medrad, Inc.",
      "count": 32
    },
    {
      "name": "Osprey Medical, Inc.",
      "count": 14
    },
    {
      "name": "Coeur, Inc.",
      "count": 10
    },
    {
      "name": "Acist Medical Systems, Inc.",
      "count": 8
    },
    {
      "name": "Bayer Medical Care, Inc.",
      "count": 7
    }
  ],
  "topCompanies": [
    {
      "name": "Medrad Inc dba Bayer R&I",
      "count": 32,
      "spellings": 1
    },
    {
      "name": "Osprey Medical, Inc.",
      "count": 15,
      "spellings": 2
    },
    {
      "name": "Acist Medical Systems",
      "count": 12,
      "spellings": 2
    },
    {
      "name": "Coeur, Inc.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Bayer Medical Care, Inc.",
      "count": 7,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Fortis Biosolutions Company Limited",
      "since": "2026-05-14",
      "kNumber": "K252652"
    },
    {
      "name": "Shenzhen Maiwei Biotech Co., Ltd.",
      "since": "2026-04-16",
      "kNumber": "K253048"
    },
    {
      "name": "Zhuhai DR Medical Instruments Co., Ltd.",
      "since": "2026-03-05",
      "kNumber": "K251788"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 17,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 9,
        "expectedLow": 2.2029128883738456,
        "expectedHigh": 19.748048400164297,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 6,
        "expectedLow": 2.359774550195302,
        "expectedHigh": 15.425380059986164,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 16,
        "expectedLow": 2.225930785374297,
        "expectedHigh": 15.900176913109444,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 4,
        "expectedLow": 3.1638843305480506,
        "expectedHigh": 19.817004462746667,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 6,
        "expectedLow": 0.33866145348649124,
        "expectedHigh": 17.006453933657056,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 16.869196417795678,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 6,
        "expectedLow": 0,
        "expectedHigh": 25.433309715207226,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 10,
        "expectedLow": 0,
        "expectedHigh": 18.333750617623682,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 9,
        "expectedLow": 0,
        "expectedHigh": 19.526358616810363,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 19.426202216100858,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 17.117301698857723,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 10,
        "expectedLow": 0,
        "expectedHigh": 18.636295041919492,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 14,
        "expectedLow": 0.1278642834598341,
        "expectedHigh": 18.817971821930087,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 39,
        "expectedLow": 1.0892071518727142,
        "expectedHigh": 17.165932720813036,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 29,
        "expectedLow": 0,
        "expectedHigh": 41.007696050881705,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "DXT (Injector And Syringe, Angiographic) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class I, Class II) (Z-2296-2026, Z-1712-2026, Z-1713-2026, Z-1830-2026, Z-1831-2026). 3 first-time filers in the last 12 months, including Fortis Biosolutions Company Limited and Shenzhen Maiwei Biotech Co., Ltd (K252652, K253048, K251788). The code is crowded, scoring 80 of 100 — 86 companies hold a clearance here and 7 arrived in the last 12 months (DXT: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-2296-2026",
          "Z-1712-2026",
          "Z-1713-2026",
          "Z-1830-2026",
          "Z-1831-2026"
        ],
        "severity": 85
      },
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including Fortis Biosolutions Company Limited and Shenzhen Maiwei Biotech Co., Ltd.",
        "recordIds": [
          "K252652",
          "K253048",
          "K251788"
        ],
        "severity": 43
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 80 of 100 — 86 companies hold a clearance here and 7 arrived in the last 12 months",
        "recordIds": [
          "DXT: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%3ADXT"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADXT"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADXT"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADXT"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADXT"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADXT"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADXT"
    }
  ],
  "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": "2026-08-11T13:51:45.687Z"
}