Cleared Traditional

K202753 - iHealth Wireless No-Touch Forehead Thermometer

K202753 is an FDA 510(k) clearance for iHealth Wireless No-Touch Forehead Ther..., manufactured by Andon Health Co, Ltd.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K202753 · Andon Health Co, Ltd. · General Hospital
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Mar 2021
Decision
168d
Days
Class 2
Risk

K202753 is an FDA 510(k) clearance for the iHealth Wireless No-Touch Forehead Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on March 8, 2021 after a review of 168 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Andon Health Co, Ltd. devices

FDA 510(k) Submission Details - K202753

510(k) Number K202753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2020
Decision Date March 08, 2021
Days to Decision 168 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 129d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLL Device Classification - Class 2, Special Controls

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2910
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLL Continuous Measurement Thermometer

All 525
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K202753.
Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603
K203707 · Shenzhen Zhengkang Technology Co., Ltd. · Mar 2021
Infrared Thermometer
K201508 · Dongguan Prestige Sporting Goods Co., Ltd. · Mar 2021
Body Infrared Thermometer HT-820D
K202591 · Dongguan Xintai Instrument Co., Ltd. · Mar 2021
Medical infrared forehead thermometer
K202111 · Hunan Honggao Electronic Technolofy Co., Ltd. · Feb 2021
Infrared Forehead Thermometer
K202420 · Conmo Electronic Company Limited · Feb 2021
Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C
K203332 · Hetaida Technology Co., Ltd. · Feb 2021