# K153146: Infrared Ear Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Sejoy Electronics & Instruments Co., Ltd.
- Decided: Mar 31, 2016 after 153 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
Longest line of descent: 2 generations back to K031928 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082192: Infrared Ear Thermometer, Model ET-101A, Sejoy Electronics & Instruments Co., Ltd. (2008) Summary page 4.

## Most influential descendants
- K181081: Infrared Ear Thermometer (2018), 0 descendants of its own

## Indications for use
Infrared Ear Thermometers, models ET-101D and ET-101H are indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment.It’s intended for use on people of all ages.

Source page: https://510kreport.com/device/K153146
Methodology: https://510kreport.com/methodology