# K232338: Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383

- Pathway: 510(k) (Traditional)
- Applicant: Alicn Medical Shenzhen, Inc.
- Decided: Dec 22, 2023 after 140 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Electronic Thermometers are intended to measure the human body temperature under arm, and the devices are non-sterile, reusable for clinical or home use on people of all ages.

Source page: https://510kreport.com/device/K232338
Methodology: https://510kreport.com/methodology