# K042627: Ear Thermometer Models ST61, ST62, ST63, ST64, and ST65

- Pathway: 510(k) (Special)
- Applicant: Mesure Technology Co., Ltd.
- Decided: Oct 18, 2004 after 21 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 K011254 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011254: Ear Thermometer, Models ST613C and ST613F, Mesure Technology (2001) Summary page 1.

## Most influential descendants
- K080981: Ear Thermometer, Models ST66 and ST67 (2008), 0 descendants of its own

## 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/K042627
Methodology: https://510kreport.com/methodology