# K210565: Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711

- Pathway: 510(k) (Traditional)
- Applicant: Alicn Medical Shenzhen, Inc.
- Decided: May 5, 2022 after 434 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 Infrared Thermometer is intended for measuring human body temperature of people aged 3 months and above by detecting infrared heat from non-contact (about 1.5-5.0cm distances) with the forehead in the home or hospital environment.

Source page: https://510kreport.com/device/K210565
Methodology: https://510kreport.com/methodology