{
  "code": "BZG",
  "deviceName": "Spirometer, Diagnostic",
  "deviceClass": "II",
  "regulationNumber": "868.1840",
  "panel": "Anesthesiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 228,
    "last12Months": 1
  },
  "adverseEvents": {
    "total": 6,
    "last12Months": 0
  },
  "reviewDays": {
    "median": 144,
    "sampleSize": 228
  },
  "recalls": {
    "total": 1,
    "recent": [
      {
        "resNumber": "Z-0324-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Baxter Healthcare Corporation",
        "firmAsPublished": "Baxter Healthcare Corporation",
        "reason": "There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),.  If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.",
        "initiated": "2024-10-11"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K251777",
      "deviceName": "MESI mTABLET SPIRO",
      "applicant": "Mesi D.O.O.",
      "company": "Mesi D.O.O.",
      "decisionDate": "2026-03-02",
      "dateReceived": "2025-06-10"
    },
    {
      "kNumber": "K241843",
      "deviceName": "TD-7301 Spirometer (TD-7301)",
      "applicant": "Gostar Co., Ltd.",
      "company": "Gostar Co., Ltd.",
      "decisionDate": "2024-11-20",
      "dateReceived": "2024-06-26"
    },
    {
      "kNumber": "K231416",
      "deviceName": "Air Next (NVD-02)",
      "applicant": "Nuvoair AB",
      "company": "Nuvoair AB",
      "decisionDate": "2024-01-18",
      "dateReceived": "2023-05-16"
    },
    {
      "kNumber": "K230501",
      "deviceName": "Spirobank Oxi",
      "applicant": "Mir Medical International Research USA",
      "company": "Mir Medical International Research USA",
      "decisionDate": "2023-12-15",
      "dateReceived": "2023-02-24"
    },
    {
      "kNumber": "K230178",
      "deviceName": "EasyOne Sky Spirometer",
      "applicant": "Ndd Medizintechnik AG",
      "company": "Ndd Medizintechnik AG",
      "decisionDate": "2023-10-19",
      "dateReceived": "2023-01-23"
    },
    {
      "kNumber": "K222525",
      "deviceName": "Alveoair Digital Spirometer",
      "applicant": "Roundworks Technologies Private Limited",
      "company": "Roundworks Technologies Private Limited",
      "decisionDate": "2023-08-28",
      "dateReceived": "2022-08-22"
    },
    {
      "kNumber": "K222443",
      "deviceName": "Air Smart Extra Spirometer",
      "applicant": "Feellife Health, Inc.",
      "company": "Feellife Health, Inc.",
      "decisionDate": "2023-08-09",
      "dateReceived": "2022-08-12"
    },
    {
      "kNumber": "K213754",
      "deviceName": "SpiroHome Personal, SpiroHome Clinic",
      "applicant": "Inofab Saglik Teknolojileri A.S",
      "company": "Inofab Saglik Teknolojileri A.S",
      "decisionDate": "2023-06-12",
      "dateReceived": "2021-11-30"
    },
    {
      "kNumber": "K213872",
      "deviceName": "ComPAS2",
      "applicant": "Morgan Scientific, Inc.",
      "company": "Morgan Scientific, Inc.",
      "decisionDate": "2022-07-15",
      "dateReceived": "2021-12-13"
    },
    {
      "kNumber": "K212938",
      "deviceName": "Vitalograph Model 6000 Alpha",
      "applicant": "Vitalograph Ireland, Ltd.",
      "company": "Vitalograph (Ireland) , Ltd.",
      "decisionDate": "2022-01-26",
      "dateReceived": "2021-09-15"
    }
  ],
  "topApplicants": [
    {
      "name": "Mir Medical Intl. Research Srl",
      "count": 9
    },
    {
      "name": "Sdi Diagnostics, Inc.",
      "count": 8
    },
    {
      "name": "Vitalograph (Ireland) , Ltd.",
      "count": 6
    },
    {
      "name": "Future Impex Corp.",
      "count": 5
    },
    {
      "name": "Medical Equipment Designs, Inc.",
      "count": 5
    }
  ],
  "topCompanies": [
    {
      "name": "Mir Medical Intl. Research Srl",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Vitalograph (Ireland) , Ltd.",
      "count": 9,
      "spellings": 2
    },
    {
      "name": "Sdi Diagnostics, Inc.",
      "count": 8,
      "spellings": 1
    },
    {
      "name": "Vitalograph , Ltd.",
      "count": 7,
      "spellings": 2
    },
    {
      "name": "Future Impex Corp.",
      "count": 5,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Mesi D.O.O.",
      "since": "2026-03-02",
      "kNumber": "K251777"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-02-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "BZG (Spirometer, Diagnostic) has two findings, most consequential first. 1 first-time filer in the last 12 months, Mesi D.O.O (K251777). The code is crowded, scoring 67 of 100 — 125 companies hold a clearance here and 1 arrived in the last 12 months (BZG:crowding).",
    "severity": 41,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Mesi D.O.O.",
        "recordIds": [
          "K251777"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 67 of 100 — 125 companies hold a clearance here and 1 arrived in the last 12 months",
        "recordIds": [
          "BZG: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%3ABZG"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ABZG"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ABZG"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ABZG"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ABZG"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ABZG"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ABZG"
    }
  ],
  "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": "2026-08-11T13:51:45.667Z"
}