# K213084: Ear Thermometer, Model ET005, ET008, ET009

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Berrcom Medical Device Co., Ltd.
- Decided: Feb 25, 2022 after 155 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: 7 generations back to K011059 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191570: Infrared Thermometer Model MD-H30, Guangzhou Berrcom Medical Device Co., Ltd. (2019) Summary page 5.

## Indications for use
The Ear Thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It is a non-contact measurement method for forehead measurement, the recommended measurement distance is Ocm to 3cm. The Ear Thermometer can be used by consumers in the household environment and by healthcare providers.

Source page: https://510kreport.com/device/K213084
Methodology: https://510kreport.com/methodology