Cleared Traditional

K212257 - Electronic Thermometer

K212257 is an FDA 510(k) clearance for Electronic 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 289-day FDA review.

K212257 · Alicn Medical (Shenzhen), Inc. · General Hospital
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May 2022
Decision
289d
Days
Class 2
Risk

K212257 is an FDA 510(k) clearance for the Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E2.... 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 May 4, 2022 after a review of 289 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 Alicn Medical (Shenzhen), Inc. devices

FDA 510(k) Submission Details - K212257

510(k) Number K212257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2021
Decision Date May 04, 2022
Days to Decision 289 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
160d slower than avg
Panel avg: 129d · This submission: 289d
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 K212257.
Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241
K210937 · Alicn Medical (Shenzhen), Inc. · May 2022
Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711
K210565 · Alicn Medical (Shenzhen), Inc. · May 2022
Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618
K212346 · Shenzhen Pango Medical Electronics Co., Ltd. · May 2022
Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)
K200946 · Taidoc Technology Corporation · Apr 2022
Infrared Thermometer (model: E201)
K213011 · Bioland Technology, Ltd. · Apr 2022
Digital thermometer, Model DT101, DT102
K213746 · Guangzhou Berrcom Medical Device Co., Ltd. · Apr 2022