{
  "code": "FLL",
  "deviceName": "Continuous Measurement Thermometer",
  "deviceClass": "II",
  "regulationNumber": "880.2910",
  "panel": "General Hospital",
  "definition": "A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals.    Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 798,
    "last12Months": 2
  },
  "adverseEvents": {
    "total": 281,
    "last12Months": 43
  },
  "reviewDays": {
    "median": 108,
    "sampleSize": 798
  },
  "recalls": {
    "total": 18,
    "recent": [
      {
        "resNumber": "Z-0233-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Baxter Healthcare Corporation",
        "firmAsPublished": "Baxter Healthcare Corporation",
        "reason": "Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.",
        "initiated": "2025-09-17"
      },
      {
        "resNumber": "Z-2339-2024",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Baxter Healthcare Corporation",
        "firmAsPublished": "Baxter Healthcare Corporation",
        "reason": "The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).",
        "initiated": "2024-06-13"
      },
      {
        "resNumber": "Z-2482-2021",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Welch Allyn Inc",
        "firmAsPublished": "Welch Allyn Inc",
        "reason": "If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient",
        "initiated": "2021-07-20"
      },
      {
        "resNumber": "Z-0990-2020",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Cardinal Health 200, LLC",
        "firmAsPublished": "Cardinal Health 200, LLC",
        "reason": "The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 and  0.3C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2C for Genius 2 or +0.3C for Genius 3.",
        "initiated": "2019-10-28"
      },
      {
        "resNumber": "Z-0991-2020",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Cardinal Health 200, LLC",
        "firmAsPublished": "Cardinal Health 200, LLC",
        "reason": "The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manual may not ensure that thermometers always remain within the stated accuracy range ( 0.2C for Genius 2 and  0.3C for Genius 3 thermometers). The measurement readings drift upwards over time, which means that the thermometers could exceed the upper stated accuracy tolerance of +0.2C for Genius 2 or +0.3C for Genius 3.",
        "initiated": "2019-10-28"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K253162",
      "deviceName": "Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)",
      "applicant": "Unimed Medical Supplies, Inc.",
      "company": "Unimed Medical Supplies, Inc.",
      "decisionDate": "2026-06-05",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K251160",
      "deviceName": "Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)",
      "applicant": "Shenzhen Med-Link Electronics Tech Co., Ltd.",
      "company": "Shenzhen Med-Link Electronics Tech Co., Ltd.",
      "decisionDate": "2026-01-08",
      "dateReceived": "2025-04-15"
    },
    {
      "kNumber": "K250470",
      "deviceName": "Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)",
      "applicant": "Shenzhen AOJ Medical Technology Co., Ltd.",
      "company": "Shenzhen AOJ Medical Technology Co., Ltd.",
      "decisionDate": "2025-06-23",
      "dateReceived": "2025-02-18"
    },
    {
      "kNumber": "K243000",
      "deviceName": "Reusable Temperature Probe (T1306, T2306, T3306, T4306);  Disposable Temperature Probe (T5106, T6106)",
      "applicant": "Shenzhen Medke Technology Co., Ltd.",
      "company": "Shenzhen Medke Technology Co., Ltd.",
      "decisionDate": "2025-06-20",
      "dateReceived": "2024-09-26"
    },
    {
      "kNumber": "K250878",
      "deviceName": "YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)",
      "applicant": "Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.",
      "company": "Jiangsu Yuyue Medical Equipment & Supply Company Limited",
      "decisionDate": "2025-05-22",
      "dateReceived": "2025-03-24"
    },
    {
      "kNumber": "K243082",
      "deviceName": "Infrared Thermometer",
      "applicant": "Guangzhou Daxin Health Technology Co., Ltd.",
      "company": "Guangzhou Daxin Health Technology Co., Ltd.",
      "decisionDate": "2025-04-25",
      "dateReceived": "2024-09-30"
    },
    {
      "kNumber": "K250401",
      "deviceName": "AION TempShield™",
      "applicant": "Aion Biosystems, Inc.",
      "company": "Aion Biosystems, Inc.",
      "decisionDate": "2025-03-14",
      "dateReceived": "2025-02-12"
    },
    {
      "kNumber": "K243136",
      "deviceName": "Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207,  FC-IR209)",
      "applicant": "Shenzhen Finicare Co., Ltd.",
      "company": "Shenzhen Finicare Co., Ltd.",
      "decisionDate": "2025-02-14",
      "dateReceived": "2024-09-30"
    },
    {
      "kNumber": "K240333",
      "deviceName": "Wearable Digital Thermometer (T31)",
      "applicant": "Guangdong Genial Technology Co., Ltd.",
      "company": "Guangdong Genial Technology Co., Ltd.",
      "decisionDate": "2024-10-30",
      "dateReceived": "2024-02-05"
    },
    {
      "kNumber": "K240223",
      "deviceName": "FMT Disposable and Autoclavable Temperature Probes",
      "applicant": "Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi",
      "company": "Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi",
      "decisionDate": "2024-10-25",
      "dateReceived": "2024-01-26"
    }
  ],
  "topApplicants": [
    {
      "name": "Microlife Intellectual Property GmbH",
      "count": 20
    },
    {
      "name": "R & D Batteries, Inc.",
      "count": 19
    },
    {
      "name": "Taidoc Technology Corporation",
      "count": 16
    },
    {
      "name": "Radiant Innovation, Inc.",
      "count": 15
    },
    {
      "name": "K-Jump Health Co., Ltd.",
      "count": 14
    }
  ],
  "topCompanies": [
    {
      "name": "Microlife Intellectual Property GmbH",
      "count": 20,
      "spellings": 1
    },
    {
      "name": "R & D Batteries, Inc.",
      "count": 19,
      "spellings": 1
    },
    {
      "name": "Taidoc Technology Corporation",
      "count": 16,
      "spellings": 1
    },
    {
      "name": "Radiant Innovation, Inc.",
      "count": 15,
      "spellings": 1
    },
    {
      "name": "K-Jump Health Co., Ltd.",
      "count": 14,
      "spellings": 1
    }
  ],
  "newEntrants": [],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 7,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 13,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 8,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 3,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 10,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 14,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 6,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 16,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 5,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 8,
        "expectedLow": 1.2954991128705862,
        "expectedHigh": 16.271027365841135,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 3,
        "expectedLow": 0.8823295233168797,
        "expectedHigh": 13.965452076369651,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 5,
        "expectedLow": 0,
        "expectedHigh": 14.718555362831237,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 9,
        "expectedLow": 0,
        "expectedHigh": 14.373904867164576,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 8,
        "expectedLow": 0.25557964208720807,
        "expectedHigh": 13.340282039460423,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 6,
        "expectedLow": 0.6235555580984176,
        "expectedHigh": 14.13607068677405,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 8,
        "expectedLow": 0.4226819564079871,
        "expectedHigh": 21.73736242955647,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 6,
        "expectedLow": 0,
        "expectedHigh": 15.412131417842524,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 3,
        "expectedLow": 0,
        "expectedHigh": 14.876475486866504,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 8,
        "expectedLow": 0,
        "expectedHigh": 14.244662293764103,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 3,
        "expectedLow": 0.5863411246861651,
        "expectedHigh": 11.482991771202558,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 6,
        "expectedLow": 0.33678403691771547,
        "expectedHigh": 10.797114555212552,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 9,
        "expectedLow": 0.6556329643384003,
        "expectedHigh": 12.627587313863609,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 5,
        "expectedLow": 1.3539596510244067,
        "expectedHigh": 10.930064663894033,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 4,
        "expectedLow": 1.2918801840737877,
        "expectedHigh": 11.484627060532606,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "FLL (Continuous Measurement Thermometer) has two findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-0233-2026). The code is crowded, scoring 68 of 100 — 415 companies hold a clearance here and 2 arrived in the last 12 months (FLL:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-0233-2026"
        ],
        "severity": 75
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 68 of 100 — 415 companies hold a clearance here and 2 arrived in the last 12 months",
        "recordIds": [
          "FLL: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%3AFLL"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFLL"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AFLL"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AFLL"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AFLL"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AFLL"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AFLL"
    }
  ],
  "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": "2026-08-11T13:51:45.696Z"
}