{
  "code": "CAH",
  "deviceName": "Filter, Bacterial, Breathing-Circuit",
  "deviceClass": "II",
  "regulationNumber": "868.5260",
  "panel": "Anesthesiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 202,
    "last12Months": 2
  },
  "adverseEvents": {
    "total": 183,
    "last12Months": 46
  },
  "reviewDays": {
    "median": 87,
    "sampleSize": 202
  },
  "recalls": {
    "total": 28,
    "recent": [
      {
        "resNumber": "Z-0449-2026",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Medline Industries, LP",
        "firmAsPublished": "Medline Industries, LP",
        "reason": "Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120\" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.",
        "initiated": "2025-10-10"
      },
      {
        "resNumber": "Z-2158-2025",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Draeger, Inc.",
        "firmAsPublished": "Draeger, Inc.",
        "reason": "Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.",
        "initiated": "2025-06-16"
      },
      {
        "resNumber": "Z-2159-2025",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Draeger, Inc.",
        "firmAsPublished": "Draeger, Inc.",
        "reason": "Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.",
        "initiated": "2025-06-16"
      },
      {
        "resNumber": "Z-2160-2025",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Draeger, Inc.",
        "firmAsPublished": "Draeger, Inc.",
        "reason": "Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.",
        "initiated": "2025-06-16"
      },
      {
        "resNumber": "Z-2161-2025",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "Draeger, Inc.",
        "firmAsPublished": "Draeger, Inc.",
        "reason": "Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.",
        "initiated": "2025-06-16"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K252643",
      "deviceName": "Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled",
      "applicant": "Teleflex Medical Sdn. Bhd.",
      "company": "Teleflex Medical",
      "decisionDate": "2026-05-15",
      "dateReceived": "2025-08-21"
    },
    {
      "kNumber": "K251583",
      "deviceName": "Ambu® Virobac II® Exhalation Filter",
      "applicant": "Ambu A/S",
      "company": "Ambu A/S",
      "decisionDate": "2026-04-30",
      "dateReceived": "2025-05-23"
    },
    {
      "kNumber": "K241339",
      "deviceName": "Besmed Bacterial Filter and HMEF",
      "applicant": "Besmed Health Business Corp",
      "company": "Besmed Health Business Corporation",
      "decisionDate": "2024-11-14",
      "dateReceived": "2024-05-13"
    },
    {
      "kNumber": "K222917",
      "deviceName": "Breathing circuit bacterial/viral filter",
      "applicant": "Shaoxing Haitech Medical Products Co., Ltd.",
      "company": "Shaoxing Haitech Medical Products Co., Ltd.",
      "decisionDate": "2024-02-15",
      "dateReceived": "2022-09-26"
    },
    {
      "kNumber": "K230483",
      "deviceName": "Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)",
      "applicant": "Passy-Muir, Inc.",
      "company": "Passy-Muir, Inc.",
      "decisionDate": "2023-09-16",
      "dateReceived": "2023-02-23"
    },
    {
      "kNumber": "K223258",
      "deviceName": "TNI Clear-Guard™ 3 angled breathing filter (1545020)",
      "applicant": "Intersurgical , Ltd.",
      "company": "Intersurgical Inc",
      "decisionDate": "2023-06-15",
      "dateReceived": "2022-10-21"
    },
    {
      "kNumber": "K221472",
      "deviceName": "Filter and HME/Filter",
      "applicant": "Ningbo Huakun Medical Equipment Co., Ltd.",
      "company": "Ningbo Huakun Medical Equipment Co., Ltd.",
      "decisionDate": "2023-02-08",
      "dateReceived": "2022-05-20"
    },
    {
      "kNumber": "K221836",
      "deviceName": "Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus",
      "applicant": "Drägerwerk AG & Co. KGaA",
      "company": "Drägerwerk AG & Co. KGaA",
      "decisionDate": "2022-12-07",
      "dateReceived": "2022-06-23"
    },
    {
      "kNumber": "K221250",
      "deviceName": "EasyOne Filter",
      "applicant": "Ndd Medizintechnik AG",
      "company": "Ndd Medizintechnik AG",
      "decisionDate": "2022-11-22",
      "dateReceived": "2022-05-02"
    },
    {
      "kNumber": "K210352",
      "deviceName": "GGM Breathing Circuit Bacterial Filter",
      "applicant": "Great Group Medical Co, Ltd.",
      "company": "Great Group Medical Co, Ltd.",
      "decisionDate": "2022-03-27",
      "dateReceived": "2021-02-08"
    }
  ],
  "topApplicants": [
    {
      "name": "Intersurgical, Inc.",
      "count": 9
    },
    {
      "name": "Medipart Jerry Alexander",
      "count": 8
    },
    {
      "name": "Porous Media Corp.",
      "count": 6
    },
    {
      "name": "King Systems Corp.",
      "count": 5
    },
    {
      "name": "Mallinckrodt Medical",
      "count": 5
    }
  ],
  "topCompanies": [
    {
      "name": "Intersurgical Inc",
      "count": 11,
      "spellings": 3
    },
    {
      "name": "Medipart Jerry Alexander",
      "count": 8,
      "spellings": 1
    },
    {
      "name": "Porous Media Corporation",
      "count": 6,
      "spellings": 1
    },
    {
      "name": "Datex-Ohmeda, Inc.",
      "count": 5,
      "spellings": 2
    },
    {
      "name": "King Systems Corp.",
      "count": 5,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Ambu A/S",
      "since": "2026-04-30",
      "kNumber": "K251583"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 5,
        "expectedLow": 1.0984912042339992,
        "expectedHigh": 6.781103213956442,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 5,
        "expectedLow": 1.2178300757060143,
        "expectedHigh": 6.24856950291989,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 6,
        "expectedLow": 1.7995427079307156,
        "expectedHigh": 7.355396268349681,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 10,
        "expectedLow": 2.102200501641377,
        "expectedHigh": 8.299715560784243,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 11,
        "expectedLow": 2.0365761430510956,
        "expectedHigh": 10.332922957745025,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 5,
        "expectedLow": 2.2668190844303573,
        "expectedHigh": 13.618289152476718,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 9,
        "expectedLow": 2.079807239675575,
        "expectedHigh": 19.934278018070252,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 3,
        "expectedLow": 2.011784238200582,
        "expectedHigh": 13.80154570717838,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 5,
        "expectedLow": 0.36321374571114445,
        "expectedHigh": 13.216359353166936,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 12.638254908438658,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 3,
        "expectedLow": 0.19407965468406405,
        "expectedHigh": 11.41098129699478,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 10,
        "expectedLow": 0,
        "expectedHigh": 11.937336082289296,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 9,
        "expectedLow": 0.3509465019359608,
        "expectedHigh": 15.495169846004382,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 5,
        "expectedLow": 0.6296507084958061,
        "expectedHigh": 13.345863398284884,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 4,
        "expectedLow": 0,
        "expectedHigh": 14.13687714731651,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "CAH (Filter, Bacterial, Breathing-Circuit) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class I) (Z-0449-2026). 1 first-time filer in the last 12 months, Ambu A/S (K251583). The code is crowded, scoring 69 of 100 — 119 companies hold a clearance here and 2 arrived in the last 12 months (CAH:crowding).",
    "severity": 85,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class I)",
        "recordIds": [
          "Z-0449-2026"
        ],
        "severity": 85
      },
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Ambu A/S",
        "recordIds": [
          "K251583"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 69 of 100 — 119 companies hold a clearance here and 2 arrived in the last 12 months",
        "recordIds": [
          "CAH: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%3ACAH"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACAH"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACAH"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ACAH"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ACAH"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ACAH"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ACAH"
    }
  ],
  "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"
}