{
  "companyId": "53974",
  "slug": "masimo-corporation-53974",
  "name": "Masimo Corporation",
  "clearances": {
    "total": 112,
    "last12Months": 2,
    "first": "1997-02-06",
    "latest": "2026-07-10"
  },
  "medianReviewDays": 100,
  "productCodeCount": 13,
  "recalls": {
    "total": 16,
    "openLast12Months": 2,
    "recent": [
      {
        "resNumber": "Z-2670-2026",
        "productCode": "MHX",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-02-20",
        "reason": "Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness."
      },
      {
        "resNumber": "Z-2671-2026",
        "productCode": "MHX",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-02-20",
        "reason": "Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness."
      },
      {
        "resNumber": "Z-1536-2024",
        "productCode": "DQA",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-02-15",
        "reason": "Their is a potential that Oximeter may automatically power off and on  resulting in loss of monitoring."
      },
      {
        "resNumber": "Z-1537-2024",
        "productCode": "DQA",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-02-15",
        "reason": "Their is a potential that Oximeter may automatically power off and on  resulting in loss of monitoring."
      },
      {
        "resNumber": "Z-1538-2024",
        "productCode": "DQA",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-02-15",
        "reason": "Their is a potential that Oximeter may automatically power off and on  resulting in loss of monitoring."
      }
    ]
  },
  "registration": {
    "sites": 4,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "DQA",
      "deviceName": "Oximeter",
      "clearances": 77,
      "latest": "2023-12-15",
      "medianReviewDays": 86
    },
    {
      "code": "MWI",
      "deviceName": "Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)",
      "clearances": 12,
      "latest": "2023-03-06",
      "medianReviewDays": 228
    },
    {
      "code": "MUD",
      "deviceName": "Oximeter, Tissue Saturation",
      "clearances": 6,
      "latest": "2025-07-17",
      "medianReviewDays": 130
    },
    {
      "code": "DPS",
      "deviceName": "Electrocardiograph",
      "clearances": 3,
      "latest": "2025-04-03",
      "medianReviewDays": 164
    },
    {
      "code": "MHX",
      "deviceName": "Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)",
      "clearances": 3,
      "latest": "2026-06-04",
      "medianReviewDays": 157
    },
    {
      "code": "OLW",
      "deviceName": "Index-Generating Electroencephalograph Software",
      "clearances": 3,
      "latest": "2026-07-10",
      "medianReviewDays": 126
    },
    {
      "code": "NLF",
      "deviceName": "Oximeter, Reprocessed",
      "clearances": 2,
      "latest": "2011-07-28",
      "medianReviewDays": 134
    },
    {
      "code": "BZQ",
      "deviceName": "Monitor, Breathing Frequency",
      "clearances": 1,
      "latest": "2018-09-05",
      "medianReviewDays": 250
    },
    {
      "code": "CCK",
      "deviceName": "Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase",
      "clearances": 1,
      "latest": "2021-03-29",
      "medianReviewDays": 290
    },
    {
      "code": "FLL",
      "deviceName": "Continuous Measurement Thermometer",
      "clearances": 1,
      "latest": "2021-06-11",
      "medianReviewDays": 221
    },
    {
      "code": "MSX",
      "deviceName": "System, Network And Communication, Physiological Monitors",
      "clearances": 1,
      "latest": "2007-06-08",
      "medianReviewDays": 56
    },
    {
      "code": "OLK",
      "deviceName": "Pulse Oximeter For Over-The-Counter Use",
      "clearances": 1,
      "latest": "2024-01-31",
      "medianReviewDays": 762
    },
    {
      "code": "QYU",
      "deviceName": "Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use",
      "clearances": 1,
      "latest": "2024-05-03",
      "medianReviewDays": 135
    }
  ],
  "productCodesShown": 13,
  "productCodesTotal": "13",
  "recentClearances": [
    {
      "kNumber": "K260880",
      "deviceName": "SedLine Sedation Monitor",
      "productCode": "OLW",
      "decisionDate": "2026-07-10",
      "reviewDays": 115
    },
    {
      "kNumber": "K254209",
      "deviceName": "Radius VSM and Accessories",
      "productCode": "MHX",
      "decisionDate": "2026-06-04",
      "reviewDays": 157
    },
    {
      "kNumber": "K243324",
      "deviceName": "Masimo O3 Regional Oximeter",
      "productCode": "MUD",
      "decisionDate": "2025-07-17",
      "reviewDays": 267
    },
    {
      "kNumber": "K250757",
      "deviceName": "Radius VSM and Accessories",
      "productCode": "MHX",
      "decisionDate": "2025-05-29",
      "reviewDays": 78
    },
    {
      "kNumber": "K243305",
      "deviceName": "Masimo W1",
      "productCode": "DPS",
      "decisionDate": "2025-04-03",
      "reviewDays": 164
    },
    {
      "kNumber": "K240229",
      "deviceName": "Masimo W1",
      "productCode": "DPS",
      "decisionDate": "2024-08-08",
      "reviewDays": 192
    },
    {
      "kNumber": "K234021",
      "deviceName": "Masimo Stork",
      "productCode": "QYU",
      "decisionDate": "2024-05-03",
      "reviewDays": 135
    },
    {
      "kNumber": "K214115",
      "deviceName": "MightySat -OTC",
      "productCode": "OLK",
      "decisionDate": "2024-01-31",
      "reviewDays": 762
    },
    {
      "kNumber": "K223721",
      "deviceName": "Masimo Stork",
      "productCode": "DQA",
      "decisionDate": "2023-12-15",
      "reviewDays": 368
    },
    {
      "kNumber": "K232512",
      "deviceName": "Masimo W1",
      "productCode": "DPS",
      "decisionDate": "2023-11-17",
      "reviewDays": 91
    }
  ],
  "nameVariants": {
    "total": "6",
    "shown": [
      {
        "name": "MASIMO CORPORATION",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Masimo Corp.",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Masimo Corporation",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Masimo Corporation",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Masimo Corporation",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Masimo Corporation",
        "dataset": "device/recall",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Masimo%20Corporation%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Masimo%20Corporation%22"
  },
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
      "ingestRun": 74
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10
    }
  ],
  "retrievedAt": "2026-08-11T14:48:53.040Z"
}