Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart C — General Hospital and Personal Use Monitoring Devices](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices) → [21 CFR 880.2910](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2910) → FLL — Continuous Measurement Thermometer # FLL · Continuous Measurement Thermometer _General Hospital · 21 CFR 880.2910 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL ## Overview - **Product Code:** FLL - **Device Name:** Continuous Measurement Thermometer - **Regulation:** [21 CFR 880.2910](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/880.2910) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **3rd-party reviewable:** yes ## Identification A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover. ## Classification Rationale Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption: ## Special Controls (1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device. ## Recent Cleared Devices (20 of 797) Showing 20 most recent of 797 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251160](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K251160.md) | Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) | Shenzhen Med-Link Electronics Tech Co., Ltd. | Jan 8, 2026 | SESE | | [K250470](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K250470.md) | Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) | Shenzhen AOJ Medical Technology Co., Ltd. | Jun 23, 2025 | SESE | | [K243000](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K243000.md) | Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) | Shenzhen Medke Technology Co., Ltd. | Jun 20, 2025 | SESE | | [K250878](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K250878.md) | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | May 22, 2025 | SESE | | [K243082](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K243082.md) | Infrared Thermometer | Guangzhou Daxin Health Technology Co., Ltd. | Apr 25, 2025 | SESE | | [K250401](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K250401.md) | AION TempShield™ | Aion Biosystems, Inc. | Mar 14, 2025 | SESE | | [K243136](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K243136.md) | Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) | Shenzhen Finicare Co., Ltd. | Feb 14, 2025 | SESE | | [K240333](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K240333.md) | Wearable Digital Thermometer (T31) | Guangdong Genial Technology Co., Ltd. | Oct 30, 2024 | SESE | | [K240223](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K240223.md) | FMT Disposable and Autoclavable Temperature Probes | Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi | Oct 25, 2024 | SESE | | [K240220](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K240220.md) | Aulisa Temperature Module (TM0002) | Taiwan Aulisa Medical Devices Technologies, Inc. | Sep 27, 2024 | SESE | | [K240077](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K240077.md) | Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) | Covidien | Aug 20, 2024 | SESE | | [K233280](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K233280.md) | SteadyTemp | Steadysense GmbH | Jun 21, 2024 | SESE | | [K240648](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K240648.md) | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | Radiant Innovation, Inc. | Jun 5, 2024 | SESE | | [K240109](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K240109.md) | Medical electronic thermometer (FC01, FC02) | Zhuzhou Goldenhot Medical Technology Co., Ltd. | Apr 12, 2024 | SESE | | [K233192](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K233192.md) | Wireless Smart Thermometer | Famidoc Technology Company Limited | Apr 5, 2024 | SESE | | [K230889](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K230889.md) | Digital Thermometer | Wenzhou Yosun Medical Technology Co.,Ltd | Apr 3, 2024 | SESE | | [K240023](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K240023.md) | Probe Covers (YF-001, YF-002) | Shenzhen YI Fang Blister Packaging Co., Ltd. | Mar 1, 2024 | SESE | | [K232473](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K232473.md) | Infrared Thermometer: Model YJ600 | Zhuhai Yueja Medical Device Technology Co., Ltd. | Feb 9, 2024 | SESE | | [K231625](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K231625.md) | VitalDetect | Wellvii, Inc. | Feb 2, 2024 | SESE | | [K232678](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K232678.md) | Digital Thermometer, Model T28, T28L | Guangdong Genial Technology Co., Ltd. | Jan 31, 2024 | SESE | ## Top Applicants - Microlife Intellectual Property GmbH — 20 clearances - R & D Batteries, Inc. — 19 clearances - Taidoc Technology Corporation — 16 clearances - Radiant Innovation, Inc. — 15 clearances - K-Jump Health Co., Ltd. — 14 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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