# K041692: Infrared Ear Thermometer, ET-100 Series

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Hua'An Medical & Health Instruments Co.,
- Decided: Sep 13, 2004 after 83 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 model ET-100 series Infrared Ear Thermometer 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/K041692
Methodology: https://510kreport.com/methodology