Cleared Traditional

K210564 - Infrared Thermometer

K210564 is an FDA 510(k) clearance for Infrared Thermometer, manufactured by Alicn Medical (Shenzhen), Inc.. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K210564 · Alicn Medical (Shenzhen), Inc. · General Hospital
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Jan 2022
Decision
316d
Days
Class 2
Risk

K210564 is an FDA 510(k) clearance for the Infrared Thermometer. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by Alicn Medical (Shenzhen), Inc. (Shenzhen, CN). The FDA issued a Cleared decision on January 7, 2022 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Alicn Medical (Shenzhen), Inc. devices

FDA 510(k) Submission Details - K210564

510(k) Number K210564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2021
Decision Date January 07, 2022
Days to Decision 316 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 129d · This submission: 316d
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 361
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K210564.
iHealth infrared Ear thermometer PT5
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Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311
K213082 · Guangzhou Berrcom Medical Device Co., Ltd. · Jan 2022
Infrared Thermometer
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Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System
K200943 · Circa Scientific, LLC · Dec 2021
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K201600 · Kangfu Medical Equipment Factory · Dec 2021
Infrared forehead thermometer LD-FT-100B
K211629 · Honsun (Nantong) Co., Ltd. · Dec 2021