# K172870: Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J

- Pathway: 510(k) (Special)
- Applicant: Hangzhou Hua'An Medical&Health Instruments Co.,Ltd
- Decided: Feb 13, 2018 after 146 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 devices models ET-100A、ET-100B、ET-100D、ET-100E、ET-100G、ET-100I、ET-100J, are intended for the intermittent measurement and monitoring of human body temperature from the auditory canal by consumers in the home . they are intended for use on people of all ages.

Source page: https://510kreport.com/device/K172870
Methodology: https://510kreport.com/methodology