{
  "code": "DXQ",
  "deviceName": "Blood Pressure Cuff",
  "deviceClass": "II",
  "regulationNumber": "870.1120",
  "panel": "Cardiovascular",
  "definition": "A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder.  The cuff is used to determine a subject's blood pressure.",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 199,
    "last12Months": 6
  },
  "adverseEvents": {
    "total": 44,
    "last12Months": 17
  },
  "reviewDays": {
    "median": 81,
    "sampleSize": 199
  },
  "recalls": {
    "total": 27,
    "recent": [
      {
        "resNumber": "Z-0847-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Baxter Healthcare Corporation",
        "firmAsPublished": "Baxter Healthcare Corporation",
        "reason": "Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.",
        "initiated": "2025-10-28"
      },
      {
        "resNumber": "Z-1562-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Baxter Healthcare Corporation",
        "firmAsPublished": "Baxter Healthcare Corporation",
        "reason": "Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.",
        "initiated": "2025-03-21"
      },
      {
        "resNumber": "Z-1564-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Baxter Healthcare Corporation",
        "firmAsPublished": "Baxter Healthcare Corporation",
        "reason": "Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.",
        "initiated": "2025-03-21"
      },
      {
        "resNumber": "Z-1566-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Baxter Healthcare Corporation",
        "firmAsPublished": "Baxter Healthcare Corporation",
        "reason": "Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.",
        "initiated": "2025-03-21"
      },
      {
        "resNumber": "Z-1567-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Baxter Healthcare Corporation",
        "firmAsPublished": "Baxter Healthcare Corporation",
        "reason": "Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.",
        "initiated": "2025-03-21"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K254287",
      "deviceName": "Medline Reusable Blood Pressure Cuff",
      "applicant": "Medline Industries, LP",
      "company": "Medline Industries, LP",
      "decisionDate": "2026-06-22",
      "dateReceived": "2025-12-31"
    },
    {
      "kNumber": "K260747",
      "deviceName": "YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff",
      "applicant": "Nihon Kohden Corporation",
      "company": "Nihon Kohden Corporation",
      "decisionDate": "2026-05-06",
      "dateReceived": "2026-03-06"
    },
    {
      "kNumber": "K253089",
      "deviceName": "NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)",
      "applicant": "Shenzhen Best Electronics Co., Ltd.",
      "company": "Shenzhen Best Electronics Co., Ltd.",
      "decisionDate": "2026-02-13",
      "dateReceived": "2025-09-23"
    },
    {
      "kNumber": "K253964",
      "deviceName": "Disposable Neonatal NIBP Cuff (U1681S-C51N)",
      "applicant": "Unimed Medical Supplies, Inc.",
      "company": "Unimed Medical Supplies, Inc.",
      "decisionDate": "2026-01-09",
      "dateReceived": "2025-12-11"
    },
    {
      "kNumber": "K251745",
      "deviceName": "Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)",
      "applicant": "Baxter Healthcare Corporation",
      "company": "Baxter Healthcare Corporation",
      "decisionDate": "2025-12-16",
      "dateReceived": "2025-06-06"
    },
    {
      "kNumber": "K250765",
      "deviceName": "AViTA Arm Type Blood Pressure Monitor Cuff",
      "applicant": "Avita Corporation",
      "company": "Avita Corporation",
      "decisionDate": "2025-09-03",
      "dateReceived": "2025-03-13"
    },
    {
      "kNumber": "K251045",
      "deviceName": "Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)",
      "applicant": "Unimed Medical Supplies, Inc.",
      "company": "Unimed Medical Supplies, Inc.",
      "decisionDate": "2025-07-15",
      "dateReceived": "2025-04-03"
    },
    {
      "kNumber": "K242623",
      "deviceName": "Disposable Blood Pressure cuff; Reusable Blood Pressure cuff",
      "applicant": "Shenzhen Medke Technology Co., Ltd.",
      "company": "Shenzhen Medke Technology Co., Ltd.",
      "decisionDate": "2024-10-31",
      "dateReceived": "2024-09-03"
    },
    {
      "kNumber": "K240165",
      "deviceName": "Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer",
      "applicant": "Wenzhou Longwan Medical Device Factory",
      "company": "Wenzhou Longwan Medical Device Factory",
      "decisionDate": "2024-03-20",
      "dateReceived": "2024-01-22"
    },
    {
      "kNumber": "K233276",
      "deviceName": "Reusable Blood Pressure Cuff",
      "applicant": "Suzhou Minhua Medical Apparatus Supplies Co., Ltd.",
      "company": "Suzhou Minhua Medical Apparatus Supplies Co., Ltd.",
      "decisionDate": "2023-12-21",
      "dateReceived": "2023-09-29"
    }
  ],
  "topApplicants": [
    {
      "name": "Rudolf Riester GmbH & Co. KG",
      "count": 8
    },
    {
      "name": "Conphar, Inc.",
      "count": 6
    },
    {
      "name": "Abco Dealers, Inc.",
      "count": 5
    },
    {
      "name": "Pymah Corp.",
      "count": 5
    },
    {
      "name": "Ethox Corp.",
      "count": 4
    }
  ],
  "topCompanies": [
    {
      "name": "Rudolf Riester GmbH & Co. KG",
      "count": 8,
      "spellings": 1
    },
    {
      "name": "Conphar, Inc.",
      "count": 6,
      "spellings": 1
    },
    {
      "name": "Abco Dealers, Inc.",
      "count": 5,
      "spellings": 1
    },
    {
      "name": "Pymah Corp.",
      "count": 5,
      "spellings": 1
    },
    {
      "name": "Ethox Corp.",
      "count": 4,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Nihon Kohden Corporation",
      "since": "2026-05-06",
      "kNumber": "K260747"
    },
    {
      "name": "Shenzhen Best Electronics Co., Ltd.",
      "since": "2026-02-13",
      "kNumber": "K253089"
    },
    {
      "name": "Baxter Healthcare Corporation",
      "since": "2025-12-16",
      "kNumber": "K251745"
    },
    {
      "name": "Avita Corporation",
      "since": "2025-09-03",
      "kNumber": "K250765"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-04-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-10-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-12-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2026-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "DXQ (Blood Pressure Cuff) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-0847-2026). 4 first-time filers in the last 12 months, including Nihon Kohden Corporation and Shenzhen Best Electronics Co., Ltd (K260747, K253089, K251745, K250765). The code is crowded, scoring 86 of 100 — 136 companies hold a clearance here and 6 arrived in the last 12 months (DXQ:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-0847-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "4 first-time filers in the last 12 months, including Nihon Kohden Corporation and Shenzhen Best Electronics Co., Ltd.",
        "recordIds": [
          "K260747",
          "K253089",
          "K251745",
          "K250765"
        ],
        "severity": 44
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 86 of 100 — 136 companies hold a clearance here and 6 arrived in the last 12 months",
        "recordIds": [
          "DXQ: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%3ADXQ"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADXQ"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADXQ"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADXQ"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADXQ"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADXQ"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADXQ"
    }
  ],
  "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"
}