{
  "code": "DXN",
  "deviceName": "System, Measurement, Blood-Pressure, Non-Invasive",
  "deviceClass": "II",
  "regulationNumber": "870.1130",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 1219,
    "last12Months": 27
  },
  "adverseEvents": {
    "total": 705,
    "last12Months": 150
  },
  "reviewDays": {
    "median": 110,
    "sampleSize": 1219
  },
  "recalls": {
    "total": 36,
    "recent": [
      {
        "resNumber": "Z-1508-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "PYRAMES INC",
        "firmAsPublished": "PYRAMES INC",
        "reason": "Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in blood pressure per specification. Containment actions: 1) Ventilator lines not to touch the isolette (e.g. mattress, side rails, pillow) or patient, 2) Move affected monitor to patient's foot.",
        "initiated": "2025-02-24"
      },
      {
        "resNumber": "Z-0032-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "MEDLINE INDUSTRIES, LP - Northfield",
        "firmAsPublished": "MEDLINE INDUSTRIES, LP - Northfield",
        "reason": "It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.",
        "initiated": "2024-08-30"
      },
      {
        "resNumber": "Z-0033-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "MEDLINE INDUSTRIES, LP - Northfield",
        "firmAsPublished": "MEDLINE INDUSTRIES, LP - Northfield",
        "reason": "It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.",
        "initiated": "2024-08-30"
      },
      {
        "resNumber": "Z-0034-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "MEDLINE INDUSTRIES, LP - Northfield",
        "firmAsPublished": "MEDLINE INDUSTRIES, LP - Northfield",
        "reason": "It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.",
        "initiated": "2024-08-30"
      },
      {
        "resNumber": "Z-1509-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Baxter Healthcare Corporation",
        "firmAsPublished": "Baxter Healthcare Corporation",
        "reason": "Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.",
        "initiated": "2024-03-26"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261136",
      "deviceName": "Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)",
      "applicant": "Guangzhou Daxin Health Technology Co., Ltd.",
      "company": "Guangzhou Daxin Health Technology Co., Ltd.",
      "decisionDate": "2026-07-23",
      "dateReceived": "2026-04-07"
    },
    {
      "kNumber": "K261082",
      "deviceName": "Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)",
      "applicant": "Microlife Corporation",
      "company": "Microlife Corporation",
      "decisionDate": "2026-07-23",
      "dateReceived": "2026-04-01"
    },
    {
      "kNumber": "K253126",
      "deviceName": "Wrist Blood Pressure Monitor (XW-05)",
      "applicant": "Shenzhen Ziqing Medical Equipment Co., Ltd.",
      "company": "Shenzhen Ziqing Medical Equipment Co., Ltd.",
      "decisionDate": "2026-06-18",
      "dateReceived": "2025-09-25"
    },
    {
      "kNumber": "K260693",
      "deviceName": "VicorderCS (VCS-SYS-1100)",
      "applicant": "80 Beats Medical GmbH",
      "company": "80 Beats Medical GmbH",
      "decisionDate": "2026-06-16",
      "dateReceived": "2026-03-03"
    },
    {
      "kNumber": "K253059",
      "deviceName": "Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)",
      "applicant": "Tournicare Pty, Ltd.",
      "company": "Tournicare Pty, Ltd.",
      "decisionDate": "2026-06-15",
      "dateReceived": "2025-09-22"
    },
    {
      "kNumber": "K253124",
      "deviceName": "Upper arm electronic blood pressure monitor (XB-01)",
      "applicant": "Shenzhen Ziqing Medical Equipment Co., Ltd.",
      "company": "Shenzhen Ziqing Medical Equipment Co., Ltd.",
      "decisionDate": "2026-06-03",
      "dateReceived": "2025-09-25"
    },
    {
      "kNumber": "K253570",
      "deviceName": "Blood Pressure Monitor (W06LT)",
      "applicant": "Shenzhen Jamr Technology Co., Ltd.",
      "company": "Shenzhen Jamr Technology Co., Ltd.",
      "decisionDate": "2026-05-20",
      "dateReceived": "2025-11-17"
    },
    {
      "kNumber": "K254048",
      "deviceName": "Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)",
      "applicant": "Shenzhen Urion Technology Co., Ltd.",
      "company": "Shenzhen Urion Technology Co., Ltd.",
      "decisionDate": "2026-05-14",
      "dateReceived": "2025-12-17"
    },
    {
      "kNumber": "K253152",
      "deviceName": "BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)",
      "applicant": "Biozen, LLC",
      "company": "Biozen, LLC",
      "decisionDate": "2026-05-06",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K260260",
      "deviceName": "Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)",
      "applicant": "Honsun (Nantong) Co., Ltd.",
      "company": "Honsun (Nantong) Co., Ltd.",
      "decisionDate": "2026-04-28",
      "dateReceived": "2026-01-28"
    }
  ],
  "topApplicants": [
    {
      "name": "Andon Health Co, Ltd.",
      "count": 68
    },
    {
      "name": "Health & Life Co., Ltd.",
      "count": 55
    },
    {
      "name": "Omron Healthcare, Inc.",
      "count": 36
    },
    {
      "name": "Microlife Intellectual Property GmbH",
      "count": 33
    },
    {
      "name": "A&D Engineering, Inc.",
      "count": 25
    }
  ],
  "topCompanies": [
    {
      "name": "Andon Health Co, Ltd.",
      "count": 68,
      "spellings": 1
    },
    {
      "name": "Health & Life Corporation",
      "count": 55,
      "spellings": 1
    },
    {
      "name": "Omron Healthcare, Inc.",
      "count": 36,
      "spellings": 1
    },
    {
      "name": "Microlife Intellectual Property GmbH",
      "count": 33,
      "spellings": 1
    },
    {
      "name": "A&D Engineering, Inc.",
      "count": 25,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Guangzhou Daxin Health Technology Co., Ltd.",
      "since": "2026-07-23",
      "kNumber": "K261136"
    },
    {
      "name": "80 Beats Medical GmbH",
      "since": "2026-06-16",
      "kNumber": "K260693"
    },
    {
      "name": "Tournicare Pty, Ltd.",
      "since": "2026-06-15",
      "kNumber": "K253059"
    },
    {
      "name": "Shenzhen Ziqing Medical Equipment Co., Ltd.",
      "since": "2026-06-03",
      "kNumber": "K253124"
    },
    {
      "name": "Biozen, LLC",
      "since": "2026-05-06",
      "kNumber": "K253152"
    },
    {
      "name": "Beijing Hanvon Health Technology Co., Ltd.",
      "since": "2026-04-21",
      "kNumber": "K253982"
    },
    {
      "name": "Shenzhen HanHan Technology Co., Ltd.",
      "since": "2026-04-01",
      "kNumber": "K254225"
    },
    {
      "name": "Ningbo Ranor Medical Technology Co., Ltd.",
      "since": "2026-01-09",
      "kNumber": "K253142"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 19,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 17,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 22,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 32,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 103,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 9,
        "expectedLow": 0,
        "expectedHigh": 69.14527920336364,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 13,
        "expectedLow": 0,
        "expectedHigh": 56.343542959026976,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 22,
        "expectedLow": 0,
        "expectedHigh": 61.59448285667654,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 21,
        "expectedLow": 0,
        "expectedHigh": 64.77440226558512,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 59,
        "expectedLow": 0,
        "expectedHigh": 60.876238961016085,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 14,
        "expectedLow": 0,
        "expectedHigh": 80.59532842333466,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 19,
        "expectedLow": 0,
        "expectedHigh": 117.86397307378454,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 27,
        "expectedLow": 0,
        "expectedHigh": 84.20558378616265,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 87.88194728695224,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 83.19792511488643,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 25,
        "expectedLow": 0,
        "expectedHigh": 48.27375656279958,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 18,
        "expectedLow": 0,
        "expectedHigh": 56.918675239710886,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 26,
        "expectedLow": 0,
        "expectedHigh": 64.58441922965878,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 19,
        "expectedLow": 0,
        "expectedHigh": 54.98162249650143,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 25,
        "expectedLow": 0,
        "expectedHigh": 60.09863059787684,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "DXN (System, Measurement, Blood-Pressure, Non-Invasive) has three findings, most consequential first. 8 first-time filers in the last 12 months, including Guangzhou Daxin Health Technology Co., Ltd. and 80 Beats Medical GmbH (K261136, K260693, K253059, K253124, K253152). Clearances are running 35% slower — a median 148 days over the last 12 months against 110 days all-time (elapsed calendar days, not FDA review days) (DXN:review_time:12m). The code is crowded, scoring 100 of 100 — 445 companies hold a clearance here and 27 arrived in the last 12 months (DXN:crowding).",
    "severity": 48,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "8 first-time filers in the last 12 months, including Guangzhou Daxin Health Technology Co., Ltd. and 80 Beats Medical GmbH",
        "recordIds": [
          "K261136",
          "K260693",
          "K253059",
          "K253124",
          "K253152"
        ],
        "severity": 48
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 35% slower — a median 148 days over the last 12 months against 110 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "DXN:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 100 of 100 — 445 companies hold a clearance here and 27 arrived in the last 12 months",
        "recordIds": [
          "DXN: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%3ADXN"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADXN"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADXN"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADXN"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADXN"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADXN"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADXN"
    }
  ],
  "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": "2026-08-11T13:51:45.686Z"
}