{
  "code": "CAW",
  "deviceName": "Generator, Oxygen, Portable",
  "deviceClass": "II",
  "regulationNumber": "868.5440",
  "panel": "Anesthesiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 287,
    "last12Months": 13
  },
  "adverseEvents": {
    "total": 1407,
    "last12Months": 423
  },
  "reviewDays": {
    "median": 104,
    "sampleSize": 287
  },
  "recalls": {
    "total": 44,
    "recent": [
      {
        "resNumber": "Z-1815-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "3B Medical, Inc.",
        "firmAsPublished": "3B Medical, Inc.",
        "reason": "Devices which did not meet internal quality specifications were inadvertently distributed.",
        "initiated": "2026-02-04"
      },
      {
        "resNumber": "Z-0481-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips Respironics, Inc.",
        "firmAsPublished": "Philips Respironics, Inc.",
        "reason": "Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device.  If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user.  This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.",
        "initiated": "2025-10-07"
      },
      {
        "resNumber": "Z-1980-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Ohio Medical Corporation",
        "firmAsPublished": "Ohio Medical Corporation",
        "reason": "Erroneous calibration values, potentially resulting in:  as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect.",
        "initiated": "2025-05-08"
      },
      {
        "resNumber": "Z-1727-2025",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Medical Depot Inc.",
        "firmAsPublished": "Medical Depot Inc.",
        "reason": "Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.",
        "initiated": "2025-04-11"
      },
      {
        "resNumber": "Z-0795-2025",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD",
        "firmAsPublished": "JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD",
        "reason": "Oxygen concentrator may melt or catch on fire during use.",
        "initiated": "2024-12-09"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K252399",
      "deviceName": "Portable Oxygen Concentrator",
      "applicant": "Honsun (Nantong) Co., Ltd.",
      "company": "Honsun (Nantong) Co., Ltd.",
      "decisionDate": "2026-06-17",
      "dateReceived": "2025-07-31"
    },
    {
      "kNumber": "K252965",
      "deviceName": "Oxygen Concentrator (OX-5A, OX-5C)",
      "applicant": "Oxytek Medical Technology Co., Ltd.",
      "company": "Oxytek Medical Technology Co., Ltd.",
      "decisionDate": "2026-05-29",
      "dateReceived": "2025-09-17"
    },
    {
      "kNumber": "K252407",
      "deviceName": "OxyGo Portable Oxygen Concentrator (1400-7000)",
      "applicant": "Mv Life, LLC",
      "company": "Mv Life, LLC",
      "decisionDate": "2026-04-23",
      "dateReceived": "2025-07-31"
    },
    {
      "kNumber": "K253549",
      "deviceName": "DeVilbiss 5 Liter Oxygen Concentrator (555)",
      "applicant": "Devilbiss Healthcare, LLC",
      "company": "DeVilbiss Healthcare LLC",
      "decisionDate": "2026-03-26",
      "dateReceived": "2025-11-14"
    },
    {
      "kNumber": "K251534",
      "deviceName": "Oxygen Concentrator (J10A)",
      "applicant": "Foshan Kycare Medical Equipment Co., Ltd.",
      "company": "Foshan Kycare Medical Equipment Co., Ltd.",
      "decisionDate": "2025-12-29",
      "dateReceived": "2025-05-19"
    },
    {
      "kNumber": "K252616",
      "deviceName": "Portable oxygen concentrator (JLO-190P)",
      "applicant": "Shenzhen Homed Medical Device Co., Ltd.",
      "company": "Shenzhen Homed Medical Device Co., Ltd.",
      "decisionDate": "2025-12-22",
      "dateReceived": "2025-08-19"
    },
    {
      "kNumber": "K251764",
      "deviceName": "Oxygen Concentrator-P2-O5E",
      "applicant": "Qingdao Kingon Medical Science and Technology Co., Ltd.",
      "company": "Qingdao Kingon Medical Science and Technology Co., Ltd.",
      "decisionDate": "2025-12-22",
      "dateReceived": "2025-06-09"
    },
    {
      "kNumber": "K252268",
      "deviceName": "V series portable oxygen concentrator (V5, V5C, V6, V6C)",
      "applicant": "Shenzhen Harveymed Technology Co., Ltd.",
      "company": "Shenzhen Harveymed Technology Co., Ltd.",
      "decisionDate": "2025-12-16",
      "dateReceived": "2025-07-21"
    },
    {
      "kNumber": "K250805",
      "deviceName": "DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)",
      "applicant": "Devilbiss Healthcare, LLC",
      "company": "DeVilbiss Healthcare LLC",
      "decisionDate": "2025-12-09",
      "dateReceived": "2025-03-17"
    },
    {
      "kNumber": "K251607",
      "deviceName": "Oxygen Concentrator (J5A)",
      "applicant": "Foshan Kycare Medical Equipment Co., Ltd.",
      "company": "Foshan Kycare Medical Equipment Co., Ltd.",
      "decisionDate": "2025-11-21",
      "dateReceived": "2025-05-27"
    }
  ],
  "topApplicants": [
    {
      "name": "Invacare Corp.",
      "count": 15
    },
    {
      "name": "Mountain Medical Equipment, Inc.",
      "count": 12
    },
    {
      "name": "The John Bunn Co.",
      "count": 8
    },
    {
      "name": "Airsep Corp.",
      "count": 7
    },
    {
      "name": "Nidek Medical Products, Inc.",
      "count": 7
    }
  ],
  "topCompanies": [
    {
      "name": "Invacare Corporation",
      "count": 20,
      "spellings": 2
    },
    {
      "name": "Mountain Medical Equipment, Inc.",
      "count": 12,
      "spellings": 1
    },
    {
      "name": "Airsep Corporation",
      "count": 8,
      "spellings": 2
    },
    {
      "name": "The John Bunn Co.",
      "count": 8,
      "spellings": 1
    },
    {
      "name": "Nidek Medical Products Inc",
      "count": 7,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Honsun (Nantong) Co., Ltd.",
      "since": "2026-06-17",
      "kNumber": "K252399"
    },
    {
      "name": "Oxytek Medical Technology Co., Ltd.",
      "since": "2026-05-29",
      "kNumber": "K252965"
    },
    {
      "name": "Mv Life, LLC",
      "since": "2026-04-23",
      "kNumber": "K252407"
    },
    {
      "name": "Shenzhen Homed Medical Device Co., Ltd.",
      "since": "2025-12-22",
      "kNumber": "K252616"
    },
    {
      "name": "Shenzhen Harveymed Technology Co., Ltd.",
      "since": "2025-12-16",
      "kNumber": "K252268"
    },
    {
      "name": "Foshan Kycare Medical Equipment Co., Ltd.",
      "since": "2025-11-21",
      "kNumber": "K251607"
    },
    {
      "name": "Nanjing Yinuoji Medical Technology Co., Ltd.",
      "since": "2025-08-27",
      "kNumber": "K250625"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 85,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 41,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 20,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 71,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 38,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 45,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 30,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 21,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 58,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 32,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 18,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 27,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 27,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 58,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 33,
        "expectedLow": 3.313987848905954,
        "expectedHigh": 66.39544638531486,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 24,
        "expectedLow": 8.827918206356028,
        "expectedHigh": 49.857146122209016,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 66,
        "expectedLow": 8.552279817710282,
        "expectedHigh": 53.901795139256976,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 34,
        "expectedLow": 12.099367252730486,
        "expectedHigh": 74.22009053293682,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 39,
        "expectedLow": 9.270334097696473,
        "expectedHigh": 66.06555922177196,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 52,
        "expectedLow": 9.923577448312356,
        "expectedHigh": 68.8423186168836,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 48,
        "expectedLow": 21.481507857115346,
        "expectedHigh": 115.49774271730664,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 67,
        "expectedLow": 12.378530368373788,
        "expectedHigh": 81.12883006479004,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 64,
        "expectedLow": 16.794580140955368,
        "expectedHigh": 93.99045542425083,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 54,
        "expectedLow": 22.200036779896,
        "expectedHigh": 93.21471677963582,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 59,
        "expectedLow": 21.590562127059382,
        "expectedHigh": 80.46939685914111,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 58,
        "expectedLow": 29.50627162568393,
        "expectedHigh": 89.7949794070354,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 41,
        "expectedLow": 33.47627538857172,
        "expectedHigh": 102.30057353464804,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 33,
        "expectedLow": 20.49571504764186,
        "expectedHigh": 80.53494299120396,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 64,
        "expectedLow": 17.518973897781553,
        "expectedHigh": 83.16568762800756,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "CAW (Generator, Oxygen, Portable) has four findings, most consequential first. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1815-2026, Z-0481-2026). 7 first-time filers in the last 12 months, including Honsun (Nantong) Co., Ltd. and Oxytek Medical Technology Co., Ltd (K252399, K252965, K252407, K252616, K252268). Clearances are running 88% slower — a median 196 days over the last 12 months against 104 days all-time (elapsed calendar days, not FDA review days) (CAW:review_time:12m). The code is crowded, scoring 95 of 100 — 141 companies hold a clearance here and 13 arrived in the last 12 months (CAW:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "2 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1815-2026",
          "Z-0481-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "7 first-time filers in the last 12 months, including Honsun (Nantong) Co., Ltd. and Oxytek Medical Technology Co., Ltd.",
        "recordIds": [
          "K252399",
          "K252965",
          "K252407",
          "K252616",
          "K252268"
        ],
        "severity": 47
      },
      {
        "kind": "review_time_shift",
        "detail": "clearances are running 88% slower — a median 196 days over the last 12 months against 104 days all-time (elapsed calendar days, not FDA review days)",
        "recordIds": [
          "CAW:review_time:12m"
        ],
        "severity": 30
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 95 of 100 — 141 companies hold a clearance here and 13 arrived in the last 12 months",
        "recordIds": [
          "CAW: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%3ACAW"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACAW"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACAW"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ACAW"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ACAW"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ACAW"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ACAW"
    }
  ],
  "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": "2026-08-11T13:51:45.669Z"
}