Cleared Traditional

K232338 - Electronic Thermometer

K232338 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 140-day FDA review.

K232338 · Alicn Medical (Shenzhen), Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
140d
Days
Class 2
Risk

K232338 is an FDA 510(k) clearance for the Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F3.... 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 December 22, 2023 after a review of 140 days - within the typical 510(k) review window.

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 - K232338

510(k) Number K232338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2023
Decision Date December 22, 2023
Days to Decision 140 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
11d slower than avg
Panel avg: 129d · This submission: 140d
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 K232338.
Infrared Thermometer: Model YJ600
K232473 · Zhuhai Yueja Medical Device Technology Co., Ltd. · Feb 2024
VitalDetect
K231625 · Wellvii, Inc. · Feb 2024
Digital Thermometer, Model T28, T28L
K232678 · Guangdong Genial Technology Co., Ltd. · Jan 2024
THERMOCLICK
K222057 · T&R BIOFAB CO., Ltd. · Dec 2023
Infrared Thermometer (AOJ-20A)
K232128 · Shenzhen AOJ Medical Technology Co., Ltd. · Oct 2023
Reusable Temperature Probe, Disposable Temperature Probe
K223807 · Shenzhen Sino-K Medical Technology Co.,Ltd · Aug 2023