# K082192: Infrared Ear Thermometer, Model ET-101A

- Pathway: 510(k) (Abbreviated)
- Applicant: Sejoy Electronics & Instruments Co., Ltd.
- Decided: Sep 17, 2008 after 44 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: 1 generation back to K031928 (2003). 1 ancestor in all.
2 later devices descend 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)
- K031928: Braun Thermoscan Pro 4000 Series (Professional Use Environment); Braun Thermoscan Irt 4000 Series (Home Use Environment), Braun GmbH (2003) Summary page 1.

## Most influential descendants
- K153146: Infrared Ear Thermometer (2016), 1 descendant of its own
- K181081: Infrared Ear Thermometer (2018), 0 descendants of its own

## Indications for use
Infrared Ear Thermometer ET-101A is 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/K082192
Methodology: https://510kreport.com/methodology