# K080981: Ear Thermometer, Models ST66 and ST67

- Pathway: 510(k) (Special)
- Applicant: Mesure Technology Co., Ltd.
- Decided: May 2, 2008 after 25 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 K011254 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042627: Ear Thermometer Models ST61, ST62, ST63, ST64, and ST65, Mesure Technology Co., Ltd. (2004). Our reading of the summary gave K040627, FDA’s number for Depuy Asr Modular Acetabular Cup System (DePuy Orthopaedics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ear Thermometer Model ST64 & ST65”.

## Indications for use
The device measures the body temperature from the auditory canal of of a patient by means of an infrared sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for home use on people of all ages.

Source page: https://510kreport.com/device/K080981
Methodology: https://510kreport.com/methodology