{
  "code": "CCK",
  "deviceName": "Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase",
  "deviceClass": "II",
  "regulationNumber": "868.1400",
  "panel": "Anesthesiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 306,
    "last12Months": 3
  },
  "adverseEvents": {
    "total": 4156,
    "last12Months": 751
  },
  "reviewDays": {
    "median": 100,
    "sampleSize": 306
  },
  "recalls": {
    "total": 84,
    "recent": [
      {
        "resNumber": "Z-1722-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Philips North America LLC",
        "firmAsPublished": "Philips North America Llc",
        "reason": "Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.",
        "initiated": "2025-04-07"
      },
      {
        "resNumber": "Z-1376-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Oridion Medical 1987 Ltd.",
        "firmAsPublished": "Oridion Medical 1987 Ltd.",
        "reason": "Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.",
        "initiated": "2025-02-17"
      },
      {
        "resNumber": "Z-1377-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Oridion Medical 1987 Ltd.",
        "firmAsPublished": "Oridion Medical 1987 Ltd.",
        "reason": "Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.",
        "initiated": "2025-02-17"
      },
      {
        "resNumber": "Z-1378-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Oridion Medical 1987 Ltd.",
        "firmAsPublished": "Oridion Medical 1987 Ltd.",
        "reason": "Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.",
        "initiated": "2025-02-17"
      },
      {
        "resNumber": "Z-1379-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Oridion Medical 1987 Ltd.",
        "firmAsPublished": "Oridion Medical 1987 Ltd.",
        "reason": "Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.",
        "initiated": "2025-02-17"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261633",
      "deviceName": "VisuBreath",
      "applicant": "Affirm Medical Technologies II, LLC",
      "company": "Affirm Medical Technologies II, LLC",
      "decisionDate": "2026-07-14",
      "dateReceived": "2026-05-18"
    },
    {
      "kNumber": "K253030",
      "deviceName": "Capnostream™35 Portable Respiratory Monitor (PM35MN)",
      "applicant": "Covidien, LLC",
      "company": "Covidien",
      "decisionDate": "2026-05-01",
      "dateReceived": "2025-09-19"
    },
    {
      "kNumber": "K250148",
      "deviceName": "Medical Gas Analyzer (AG200)",
      "applicant": "Prior Care Science Technology, Ltd.",
      "company": "Prior Care Science Technology, Ltd.",
      "decisionDate": "2025-08-28",
      "dateReceived": "2025-01-21"
    },
    {
      "kNumber": "K243956",
      "deviceName": "TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)",
      "applicant": "Nihon Kohden Corporation",
      "company": "Nihon Kohden Corporation",
      "decisionDate": "2025-06-10",
      "dateReceived": "2024-12-23"
    },
    {
      "kNumber": "K251216",
      "deviceName": "0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line",
      "applicant": "Barbaras Development, Inc.",
      "company": "Barbaras Development, Inc.",
      "decisionDate": "2025-06-04",
      "dateReceived": "2025-04-18"
    },
    {
      "kNumber": "K240937",
      "deviceName": "AIM (N/A)",
      "applicant": "Inventeur, LLC",
      "company": "Inventeur, LLC",
      "decisionDate": "2024-12-16",
      "dateReceived": "2024-04-05"
    },
    {
      "kNumber": "K230915",
      "deviceName": "AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask",
      "applicant": "Vyaire Medical, Inc.",
      "company": "Vyaire Medical, Inc.",
      "decisionDate": "2024-11-12",
      "dateReceived": "2023-03-31"
    },
    {
      "kNumber": "K212425",
      "deviceName": "MicroTrend System",
      "applicant": "Exostat Medical, Inc.",
      "company": "Exostat Medical, Inc.",
      "decisionDate": "2024-11-07",
      "dateReceived": "2021-08-04"
    },
    {
      "kNumber": "K222511",
      "deviceName": "Oxy2Pro",
      "applicant": "Southmedic, Inc.",
      "company": "Southmedic, Inc.",
      "decisionDate": "2023-11-21",
      "dateReceived": "2022-08-19"
    },
    {
      "kNumber": "K213767",
      "deviceName": "Endure ETCO2/02 Nasal Cannula",
      "applicant": "Endure Industries, Inc.",
      "company": "Endure Industries, Inc.",
      "decisionDate": "2023-09-12",
      "dateReceived": "2021-12-01"
    }
  ],
  "topApplicants": [
    {
      "name": "Oridion Medical 1987 , Ltd.",
      "count": 17
    },
    {
      "name": "Datex Division Instrumentarium Corp.",
      "count": 9
    },
    {
      "name": "Nihon Kohden America, Inc.",
      "count": 9
    },
    {
      "name": "Salter Labs",
      "count": 8
    },
    {
      "name": "Biochem International, Inc.",
      "count": 6
    }
  ],
  "topCompanies": [
    {
      "name": "Oridion Medical 1987 Ltd.",
      "count": 17,
      "spellings": 1
    },
    {
      "name": "Datex Division Instrumentarium Corp.",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Nihon Kohden America Inc",
      "count": 9,
      "spellings": 1
    },
    {
      "name": "Salter Labs",
      "count": 8,
      "spellings": 1
    },
    {
      "name": "Biochem International, Inc.",
      "count": 6,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Affirm Medical Technologies II, LLC",
      "since": "2026-07-14",
      "kNumber": "K261633"
    },
    {
      "name": "Prior Care Science Technology, Ltd.",
      "since": "2025-08-28",
      "kNumber": "K250148"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 83,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 163,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 208,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 186,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 264,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 133,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 113,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 138,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 100,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 60,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 79,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 72,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 77,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 97,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 88,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 90,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 126,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 137,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 121,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 141,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 128,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 56,
        "expectedLow": 66.08651013158504,
        "expectedHigh": 157.4131219190159,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 62,
        "expectedLow": 42.706146137069595,
        "expectedHigh": 123.30229650351048,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 90,
        "expectedLow": 39.65632551110753,
        "expectedHigh": 131.8675236454143,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 159,
        "expectedLow": 44.2574646963484,
        "expectedHigh": 135.80440363762938,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 89,
        "expectedLow": 50.80982660907581,
        "expectedHigh": 157.19780848405395,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 58,
        "expectedLow": 48.235704641756506,
        "expectedHigh": 158.1199823040352,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 207,
        "expectedLow": 46.16550052903945,
        "expectedHigh": 235.0940597728406,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 97,
        "expectedLow": 48.74543985658738,
        "expectedHigh": 194.97232884262198,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 71,
        "expectedLow": 42.5684448518643,
        "expectedHigh": 198.7266999123909,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 114,
        "expectedLow": 24.01985369137798,
        "expectedHigh": 185.33203546941743,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 97,
        "expectedLow": 24.762443198438064,
        "expectedHigh": 169.74369109389974,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 120,
        "expectedLow": 31.64118291197643,
        "expectedHigh": 183.1946833642033,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 103,
        "expectedLow": 41.71201155734491,
        "expectedHigh": 212.61089758443825,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 76,
        "expectedLow": 32.770948183267016,
        "expectedHigh": 170.60188245775143,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 110,
        "expectedLow": 26.47687162191327,
        "expectedHigh": 180.34711314724711,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) has two findings, most consequential first. 2 first-time filers in the last 12 months, Affirm Medical Technologies II, LLC and Prior Care Science Technology, Ltd (K261633, K250148). The code is crowded, scoring 78 of 100 — 151 companies hold a clearance here and 3 arrived in the last 12 months (CCK:crowding).",
    "severity": 42,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "2 first-time filers in the last 12 months, Affirm Medical Technologies II, LLC and Prior Care Science Technology, Ltd.",
        "recordIds": [
          "K261633",
          "K250148"
        ],
        "severity": 42
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 78 of 100 — 151 companies hold a clearance here and 3 arrived in the last 12 months",
        "recordIds": [
          "CCK: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%3ACCK"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACCK"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACCK"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ACCK"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ACCK"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ACCK"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ACCK"
    }
  ],
  "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": "2026-08-11T13:51:45.671Z"
}