# K250470: Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen AOJ Medical Technology Co., Ltd.
- Decided: Jun 23, 2025 after 125 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: 5 generations back to K031928 (2003). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203583: YUWELL infrared ear thermometer: YHT101, YHT200, Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. (2021) Summary page 5.

## Indications for use
The Ear Thermometer is intended to measure human body temperature of people over three months from surface of eardrum. It applies to both professional use and home use.

Source page: https://510kreport.com/device/K250470
Methodology: https://510kreport.com/methodology