{
  "code": "CAF",
  "deviceName": "Nebulizer (Direct Patient Interface)",
  "deviceClass": "II",
  "regulationNumber": "868.5630",
  "panel": "Anesthesiology",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 508,
    "last12Months": 4
  },
  "adverseEvents": {
    "total": 408,
    "last12Months": 136
  },
  "reviewDays": {
    "median": 123,
    "sampleSize": 508
  },
  "recalls": {
    "total": 36,
    "recent": [
      {
        "resNumber": "Z-2514-2023",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "firm": "MEDLINE INDUSTRIES, LP - Northfield",
        "firmAsPublished": "MEDLINE INDUSTRIES, LP - Northfield",
        "reason": "Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.",
        "initiated": "2023-08-04"
      },
      {
        "resNumber": "Z-1516-2021",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Smiths Medical ASD, Inc.",
        "firmAsPublished": "Smiths Medical ASD Inc.",
        "reason": "The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.",
        "initiated": "2021-03-31"
      },
      {
        "resNumber": "Z-1058-2019",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "SANRAI INTERNATIONAL LLC",
        "firmAsPublished": "SANRAI INTERNATIONAL LLC",
        "reason": "The product was designed for 120V usage and is being used in South Africa with 220V.  There is a potential for the device to overheat and the mouthpiece can pop off.",
        "initiated": "2018-08-29"
      },
      {
        "resNumber": "Z-0710-2019",
        "status": "Terminated",
        "recallClass": "Class I",
        "firm": "Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company",
        "firmAsPublished": "Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company",
        "reason": "Lack of sterility assurance:  leaking containers which could lead to exposure to infectious agents.",
        "initiated": "2017-09-05"
      },
      {
        "resNumber": "Z-0711-2019",
        "status": "Terminated",
        "recallClass": "Class I",
        "firm": "Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company",
        "firmAsPublished": "Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company",
        "reason": "Lack of sterility assurance:  leaking containers which could lead to exposure to infectious agents.",
        "initiated": "2017-09-05"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260270",
      "deviceName": "FindAir ONE for pMDI  (FAO-MDI-V12-GRE-001)",
      "applicant": "FindAir Sp. z o.o.",
      "company": "FindAir Sp. z o.o.",
      "decisionDate": "2026-06-02",
      "dateReceived": "2026-01-28"
    },
    {
      "kNumber": "K251572",
      "deviceName": "eRapid with eTrack System",
      "applicant": "Pari Respiratory Equipment, Inc.",
      "company": "Pari Respiratory Equipment, Inc.",
      "decisionDate": "2025-12-19",
      "dateReceived": "2025-05-22"
    },
    {
      "kNumber": "K251659",
      "deviceName": "Mesh Nebulizer (H6)",
      "applicant": "Qingdao Future Medical Technology Co., Ltd.",
      "company": "Qingdao Future Medical Technology Co., Ltd.",
      "decisionDate": "2025-11-14",
      "dateReceived": "2025-05-30"
    },
    {
      "kNumber": "K244035",
      "deviceName": "Portable mesh nebulizer (JM821)",
      "applicant": "Shenzhen Jermei Medical Device Technology Co., Ltd.",
      "company": "Shenzhen Jermei Medical Device Technology Co., Ltd.",
      "decisionDate": "2025-09-19",
      "dateReceived": "2024-12-30"
    },
    {
      "kNumber": "K243468",
      "deviceName": "Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)",
      "applicant": "Joytech Healthcare Co. , Ltd.",
      "company": "Joytech Healthcare Co. , Ltd.",
      "decisionDate": "2025-07-02",
      "dateReceived": "2024-11-08"
    },
    {
      "kNumber": "K250022",
      "deviceName": "HeroTracker Sense",
      "applicant": "Voluntis",
      "company": "Voluntis",
      "decisionDate": "2025-06-30",
      "dateReceived": "2025-01-03"
    },
    {
      "kNumber": "K250583",
      "deviceName": "AdheResp Smart Breath-actuated Mesh Nebulizer",
      "applicant": "Hcmed Innovations Co., Ltd.",
      "company": "Hcmed Innovations Co., Ltd.",
      "decisionDate": "2025-06-20",
      "dateReceived": "2025-02-27"
    },
    {
      "kNumber": "K242354",
      "deviceName": "AllNEB",
      "applicant": "Enchant Tek Co. , Ltd.",
      "company": "Enchant Tek Co. , Ltd.",
      "decisionDate": "2025-04-29",
      "dateReceived": "2024-08-08"
    },
    {
      "kNumber": "K233553",
      "deviceName": "MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter",
      "applicant": "Thayer Medical Corporation",
      "company": "Thayer Medical Corporation",
      "decisionDate": "2024-06-18",
      "dateReceived": "2023-11-06"
    },
    {
      "kNumber": "K232507",
      "deviceName": "Aerogen®Solo Nebulizer System",
      "applicant": "Aerogen, Ltd.",
      "company": "Aerogen Ltd.",
      "decisionDate": "2024-05-10",
      "dateReceived": "2023-08-18"
    }
  ],
  "topApplicants": [
    {
      "name": "Airlife, Inc.",
      "count": 16
    },
    {
      "name": "Vortran Medical Technology 1, Inc.",
      "count": 12
    },
    {
      "name": "Adherium (Nz), Ltd.",
      "count": 10
    },
    {
      "name": "Salter Labs",
      "count": 9
    },
    {
      "name": "Pari Innovative Manufacturers, Inc.",
      "count": 8
    }
  ],
  "topCompanies": [
    {
      "name": "Airlife, Inc.",
      "count": 16,
      "spellings": 1
    },
    {
      "name": "Vortran Medical Technology 1, Inc",
      "count": 12,
      "spellings": 1
    },
    {
      "name": "Adherium (Nz), Ltd.",
      "count": 10,
      "spellings": 1
    },
    {
      "name": "Reciprocal Labs Corporation",
      "count": 10,
      "spellings": 2
    },
    {
      "name": "Aerogen Ltd.",
      "count": 9,
      "spellings": 3
    }
  ],
  "newEntrants": [
    {
      "name": "FindAir Sp. z o.o.",
      "since": "2026-06-02",
      "kNumber": "K260270"
    },
    {
      "name": "Shenzhen Jermei Medical Device Technology Co., Ltd.",
      "since": "2025-09-19",
      "kNumber": "K244035"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 15,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 9,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 25,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 16,
        "expectedLow": 0,
        "expectedHigh": 21.75687124208737,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 12,
        "expectedLow": 0.2051529488136676,
        "expectedHigh": 21.087836299774988,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 14,
        "expectedLow": 0.9658414500817468,
        "expectedHigh": 23.935433636314894,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 20,
        "expectedLow": 1.1152585058634898,
        "expectedHigh": 25.526828094399317,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 11,
        "expectedLow": 1.7887776461486045,
        "expectedHigh": 26.818569761629384,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 11,
        "expectedLow": 2.179546988259265,
        "expectedHigh": 25.600249666553214,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 9,
        "expectedLow": 2.263845692534133,
        "expectedHigh": 38.55513388174264,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 7,
        "expectedLow": 0,
        "expectedHigh": 26.374762603046495,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 21,
        "expectedLow": 0,
        "expectedHigh": 24.902370399082525,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 44,
        "expectedLow": 2.9119927141137025,
        "expectedHigh": 26.41455921154608,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 14,
        "expectedLow": 3.6480886340336682,
        "expectedHigh": 38.38362290822069,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 9,
        "expectedLow": 1.6637528052543678,
        "expectedHigh": 40.17428901726919,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 14,
        "expectedLow": 0,
        "expectedHigh": 42.90196678255831,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 12,
        "expectedLow": 0,
        "expectedHigh": 34.87987795633452,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 15,
        "expectedLow": 0,
        "expectedHigh": 37.3063963462043,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "CAF (Nebulizer (Direct Patient Interface)) has two findings, most consequential first. 2 first-time filers in the last 12 months, FindAir Sp. z o.o. and Shenzhen Jermei Medical Device Technology Co., Ltd (K260270, K244035). The code is crowded, scoring 83 of 100 — 244 companies hold a clearance here and 4 arrived in the last 12 months (CAF:crowding).",
    "severity": 42,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "2 first-time filers in the last 12 months, FindAir Sp. z o.o. and Shenzhen Jermei Medical Device Technology Co., Ltd.",
        "recordIds": [
          "K260270",
          "K244035"
        ],
        "severity": 42
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 83 of 100 — 244 companies hold a clearance here and 4 arrived in the last 12 months",
        "recordIds": [
          "CAF: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%3ACAF"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACAF"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ACAF"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ACAF"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ACAF"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ACAF"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ACAF"
    }
  ],
  "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": "2026-08-11T13:51:45.668Z"
}