{
  "code": "DQA",
  "deviceName": "Oximeter",
  "deviceClass": "II",
  "regulationNumber": "870.2700",
  "panel": "Cardiovascular",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 726,
    "last12Months": 14
  },
  "adverseEvents": {
    "total": 1496,
    "last12Months": 433
  },
  "reviewDays": {
    "median": 125,
    "sampleSize": 726
  },
  "recalls": {
    "total": 128,
    "recent": [
      {
        "resNumber": "Z-1142-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Edan Diagnostics",
        "firmAsPublished": "Edan Diagnostics",
        "reason": "As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.",
        "initiated": "2025-10-24"
      },
      {
        "resNumber": "Z-1143-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Edan Diagnostics",
        "firmAsPublished": "Edan Diagnostics",
        "reason": "As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.",
        "initiated": "2025-10-24"
      },
      {
        "resNumber": "Z-1152-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Edan Diagnostics",
        "firmAsPublished": "Edan Diagnostics",
        "reason": "As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.",
        "initiated": "2025-10-24"
      },
      {
        "resNumber": "Z-1153-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Edan Diagnostics",
        "firmAsPublished": "Edan Diagnostics",
        "reason": "As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.",
        "initiated": "2025-10-24"
      },
      {
        "resNumber": "Z-2151-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Covidien",
        "firmAsPublished": "Covidien",
        "reason": "Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting",
        "initiated": "2025-06-23"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K252821",
      "deviceName": "Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)",
      "applicant": "Philips Medizin Systeme Böblingen GmbH",
      "company": "Philips Medizin Systeme Boblingen GmbH",
      "decisionDate": "2026-05-29",
      "dateReceived": "2025-09-04"
    },
    {
      "kNumber": "K252655",
      "deviceName": "Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO,  PO-C6AT)",
      "applicant": "Shenzhen Imdk Medical Technology Co., Ltd.",
      "company": "Shenzhen Imdk Medical Technology Co., Ltd.",
      "decisionDate": "2026-05-11",
      "dateReceived": "2025-08-22"
    },
    {
      "kNumber": "K253887",
      "deviceName": "Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)",
      "applicant": "Philips Medizin Systeme",
      "company": "Philips Medizin Systeme",
      "decisionDate": "2026-05-01",
      "dateReceived": "2025-12-04"
    },
    {
      "kNumber": "K260931",
      "deviceName": "Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)",
      "applicant": "Unimed Medical Supplies, Inc.",
      "company": "Unimed Medical Supplies, Inc.",
      "decisionDate": "2026-04-14",
      "dateReceived": "2026-03-20"
    },
    {
      "kNumber": "K252448",
      "deviceName": "AViTA Pulse Oximeter (SP61)",
      "applicant": "Avita Corporation",
      "company": "Avita Corporation",
      "decisionDate": "2026-02-27",
      "dateReceived": "2025-08-04"
    },
    {
      "kNumber": "K252805",
      "deviceName": "YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)",
      "applicant": "Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.",
      "company": "Jiangsu Yuyue Medical Equipment & Supply Company Limited",
      "decisionDate": "2026-02-17",
      "dateReceived": "2025-09-03"
    },
    {
      "kNumber": "K253109",
      "deviceName": "Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)",
      "applicant": "Shenzhen Best Electronics Co., Ltd.",
      "company": "Shenzhen Best Electronics Co., Ltd.",
      "decisionDate": "2026-01-07",
      "dateReceived": "2025-09-24"
    },
    {
      "kNumber": "K251751",
      "deviceName": "Spo2 Sensor CSS032D",
      "applicant": "Shenzhen Ykd Technology Co., Ltd.",
      "company": "Shenzhen Ykd Technology Co., Ltd.",
      "decisionDate": "2025-12-19",
      "dateReceived": "2025-06-09"
    },
    {
      "kNumber": "K251696",
      "deviceName": "Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)",
      "applicant": "Unimed Medical Supplies, Inc.",
      "company": "Unimed Medical Supplies, Inc.",
      "decisionDate": "2025-12-01",
      "dateReceived": "2025-06-02"
    },
    {
      "kNumber": "K251691",
      "deviceName": "Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)",
      "applicant": "Unimed Medical Supplies, Inc.",
      "company": "Unimed Medical Supplies, Inc.",
      "decisionDate": "2025-12-01",
      "dateReceived": "2025-06-02"
    }
  ],
  "topApplicants": [
    {
      "name": "Masimo Corporation",
      "count": 49
    },
    {
      "name": "Nonin Medical, Inc.",
      "count": 42
    },
    {
      "name": "Masimo Corp.",
      "count": 28
    },
    {
      "name": "Beijing Choice Electronic Technololgy Co., Ltd.",
      "count": 21
    },
    {
      "name": "Nellcor Puritan Bennett, Inc.",
      "count": 19
    }
  ],
  "topCompanies": [
    {
      "name": "Masimo Corporation",
      "count": 77,
      "spellings": 2
    },
    {
      "name": "Nonin Medical, Inc",
      "count": 42,
      "spellings": 1
    },
    {
      "name": "Beijing Choice Electronic Technololgy Co., Ltd.",
      "count": 21,
      "spellings": 1
    },
    {
      "name": "Nellcor Puritan Bennett Inc. (dba Covidien LP)",
      "count": 19,
      "spellings": 1
    },
    {
      "name": "Dolphin Medical, Inc.",
      "count": 12,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Philips Medizin Systeme",
      "since": "2026-05-01",
      "kNumber": "K253887"
    },
    {
      "name": "Shenzhen Best Electronics Co., Ltd.",
      "since": "2026-01-07",
      "kNumber": "K253109"
    },
    {
      "name": "Shenzhen Ykd Technology Co., Ltd.",
      "since": "2025-12-19",
      "kNumber": "K251751"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 28,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 24,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 46,
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        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 39,
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        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 23,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 26,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 37,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 39,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 34,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 61,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 88,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
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      {
        "month": "2024-04-01",
        "observed": 36,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
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        "month": "2024-05-01",
        "observed": 76,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 27,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
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      {
        "month": "2024-07-01",
        "observed": 30,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 44,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 30,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
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      {
        "month": "2024-11-01",
        "observed": 74,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 29,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
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      {
        "month": "2025-01-01",
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        "expectedLow": 0,
        "expectedHigh": 82.48286894173636,
        "isSufficient": true
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      {
        "month": "2025-02-01",
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        "expectedHigh": 68.4189830577268,
        "isSufficient": true
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      {
        "month": "2025-03-01",
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        "expectedHigh": 62.986315917121196,
        "isSufficient": true
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      {
        "month": "2025-04-01",
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        "expectedHigh": 61.67077540533525,
        "isSufficient": true
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        "month": "2025-05-01",
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        "expectedHigh": 60.942377959160375,
        "isSufficient": true
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      {
        "month": "2025-06-01",
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        "expectedHigh": 54.32906620309876,
        "isSufficient": true
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      {
        "month": "2025-07-01",
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        "expectedHigh": 86.44316833882915,
        "isSufficient": true
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        "month": "2025-08-01",
        "observed": 46,
        "expectedLow": 0.2228609864527067,
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        "isSufficient": true
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      {
        "month": "2025-09-01",
        "observed": 31,
        "expectedLow": 4.094626705265172,
        "expectedHigh": 73.10715545307254,
        "isSufficient": true
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      {
        "month": "2025-10-01",
        "observed": 43,
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        "expectedHigh": 70.39627238151608,
        "isSufficient": true
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      {
        "month": "2025-11-01",
        "observed": 26,
        "expectedLow": 4.413252583873506,
        "expectedHigh": 65.65423706732255,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 66,
        "expectedLow": 16.682110866165527,
        "expectedHigh": 53.52636707427952,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 79,
        "expectedLow": 20.7544045709592,
        "expectedHigh": 81.52808970611058,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 78,
        "expectedLow": 19.479889305653444,
        "expectedHigh": 81.25718180089241,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 81,
        "expectedLow": 22.635012793192075,
        "expectedHigh": 105.40214389297053,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "DQA (Oximeter) has four findings, most consequential first. 4 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1142-2026, Z-1143-2026, Z-1152-2026, Z-1153-2026). 3 first-time filers in the last 12 months, including Philips Medizin Systeme and Shenzhen Best Electronics Co., Ltd (K253887, K253109, K251751). Clearances are running 35% slower — a median 169 days over the last 12 months against 125 days all-time (elapsed calendar days, not FDA review days) (DQA:review_time:12m). The code is crowded, scoring 94 of 100 — 261 companies hold a clearance here and 14 arrived in the last 12 months (DQA:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "4 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1142-2026",
          "Z-1143-2026",
          "Z-1152-2026",
          "Z-1153-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including Philips Medizin Systeme and Shenzhen Best Electronics Co., Ltd.",
        "recordIds": [
          "K253887",
          "K253109",
          "K251751"
        ],
        "severity": 43
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 35% slower — a median 169 days over the last 12 months against 125 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "DQA:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 94 of 100 — 261 companies hold a clearance here and 14 arrived in the last 12 months",
        "recordIds": [
          "DQA: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%3ADQA"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADQA"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADQA"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADQA"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADQA"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADQA"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADQA"
    }
  ],
  "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": "2026-08-11T13:51:45.676Z"
}