{
  "code": "DSH",
  "deviceName": "Recorder, Magnetic Tape, Medical",
  "deviceClass": "II",
  "regulationNumber": "870.2800",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 195,
    "last12Months": 4
  },
  "adverseEvents": {
    "total": 426,
    "last12Months": 207
  },
  "reviewDays": {
    "median": 83,
    "sampleSize": 195
  },
  "recalls": {
    "total": 0,
    "recent": []
  },
  "recentClearances": [
    {
      "kNumber": "K260157",
      "deviceName": "LifeLens Physiological Monitor",
      "applicant": "LifeLens Technologies, Inc.",
      "company": "LifeLens Technologies, Inc.",
      "decisionDate": "2026-07-09",
      "dateReceived": "2026-01-20"
    },
    {
      "kNumber": "K252389",
      "deviceName": "Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)",
      "applicant": "Smwmed, Inc.",
      "company": "Smwmed, Inc.",
      "decisionDate": "2026-04-23",
      "dateReceived": "2025-07-31"
    },
    {
      "kNumber": "K253293",
      "deviceName": "VitaloJAK Clinic (Model 7100)",
      "applicant": "Vitalograph , Ltd.",
      "company": "Vitalograph , Ltd.",
      "decisionDate": "2025-12-03",
      "dateReceived": "2025-09-29"
    },
    {
      "kNumber": "K243650",
      "deviceName": "Zio® monitor  (DFG0001)",
      "applicant": "iRhythm Technologies, Inc.",
      "company": "iRhythm Technologies, Inc.",
      "decisionDate": "2025-08-15",
      "dateReceived": "2024-11-26"
    },
    {
      "kNumber": "K243603",
      "deviceName": "AeviceMD",
      "applicant": "Aevice Health Pte. , Ltd.",
      "company": "Aevice Health Pte. , Ltd.",
      "decisionDate": "2025-05-05",
      "dateReceived": "2024-11-21"
    },
    {
      "kNumber": "K242583",
      "deviceName": "AT-Patch (ATP-C130/ATP-C70)",
      "applicant": "Atsens Co., Ltd.",
      "company": "Atsens Co., Ltd.",
      "decisionDate": "2025-05-02",
      "dateReceived": "2024-08-30"
    },
    {
      "kNumber": "K232670",
      "deviceName": "HiCardi+ H100",
      "applicant": "MEZOO Co., Ltd.",
      "company": "MEZOO Co., Ltd.",
      "decisionDate": "2024-09-20",
      "dateReceived": "2023-09-01"
    },
    {
      "kNumber": "K233906",
      "deviceName": "S-Patch  (S-Patch ExL)",
      "applicant": "Wellysis Corp.",
      "company": "Wellysis Corp.",
      "decisionDate": "2024-02-16",
      "dateReceived": "2023-12-12"
    },
    {
      "kNumber": "K231104",
      "deviceName": "ABPMpro",
      "applicant": "Somnomedics GmbH",
      "company": "Somnomedics GmbH",
      "decisionDate": "2023-11-27",
      "dateReceived": "2023-04-19"
    },
    {
      "kNumber": "K233110",
      "deviceName": "Carnation Ambulatory Monitor",
      "applicant": "Bardy Diagnostics, Inc.",
      "company": "Bardy Diagnostics, Inc.",
      "decisionDate": "2023-11-22",
      "dateReceived": "2023-09-27"
    }
  ],
  "topApplicants": [
    {
      "name": "Del Mar Avionics",
      "count": 15
    },
    {
      "name": "Bardy Diagnostics, Inc.",
      "count": 7
    },
    {
      "name": "Oxford Medilog, Inc.",
      "count": 6
    },
    {
      "name": "iRhythm Technologies, Inc.",
      "count": 6
    },
    {
      "name": "Cardiocomm Solutions, Inc.",
      "count": 4
    }
  ],
  "topCompanies": [
    {
      "name": "Del Mar Avionics",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "Bardy Diagnostics, Inc.",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "Oxford Medilog, Inc.",
      "count": 6,
      "spellings": 1
    },
    {
      "name": "iRhythm Technologies, Inc.",
      "count": 6,
      "spellings": 1
    },
    {
      "name": "Cardiocomm Solutions, Inc.",
      "count": 4,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Smwmed, Inc.",
      "since": "2026-04-23",
      "kNumber": "K252389"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
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        "isSufficient": false
      },
      {
        "month": "2024-06-01",
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        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
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        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
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        "isSufficient": false
      },
      {
        "month": "2024-11-01",
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        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
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        "expectedLow": 2.4305117713384625,
        "expectedHigh": 15.656584188132186,
        "isSufficient": true
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      {
        "month": "2025-02-01",
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        "isSufficient": true
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        "month": "2025-03-01",
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        "expectedHigh": 18.444747140901516,
        "isSufficient": true
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      {
        "month": "2025-04-01",
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        "expectedLow": 2.439891685554625,
        "expectedHigh": 19.8888886733176,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
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        "expectedHigh": 20.435953185968735,
        "isSufficient": true
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      {
        "month": "2025-06-01",
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        "expectedHigh": 19.233341119032122,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
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        "expectedHigh": 31.068962445106422,
        "isSufficient": true
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      {
        "month": "2025-08-01",
        "observed": 29,
        "expectedLow": 6.045334582468527,
        "expectedHigh": 20.90461892680695,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 21,
        "expectedLow": 6.627018025933512,
        "expectedHigh": 31.392614905263912,
        "isSufficient": true
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      {
        "month": "2025-10-01",
        "observed": 14,
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        "expectedHigh": 31.040975313830362,
        "isSufficient": true
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      {
        "month": "2025-11-01",
        "observed": 23,
        "expectedLow": 6.16714766818349,
        "expectedHigh": 26.063597008977922,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 33,
        "expectedLow": 8.606615338391252,
        "expectedHigh": 31.79737262246866,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 27,
        "expectedLow": 11.163743801549861,
        "expectedHigh": 44.41111781550438,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 39,
        "expectedLow": 8.989341993176268,
        "expectedHigh": 37.469822803632304,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 28,
        "expectedLow": 11.479796048621187,
        "expectedHigh": 49.8983113008081,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "DSH (Recorder, Magnetic Tape, Medical) has two findings, most consequential first. 1 first-time filer in the last 12 months, Smwmed, Inc (K252389). The code is crowded, scoring 73 of 100 — 118 companies hold a clearance here and 4 arrived in the last 12 months (DSH:crowding).",
    "severity": 41,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Smwmed, Inc.",
        "recordIds": [
          "K252389"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 73 of 100 — 118 companies hold a clearance here and 4 arrived in the last 12 months",
        "recordIds": [
          "DSH: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%3ADSH"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADSH"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADSH"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADSH"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADSH"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADSH"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADSH"
    }
  ],
  "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": "2026-08-11T13:51:45.681Z"
}