# K131155: UGFT3; FHT7

- Pathway: 510(k) (Traditional)
- Applicant: Medisim, Ltd.
- Decided: Aug 28, 2013 after 126 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: 4 generations back to K902624 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051422: Dual Mode UP-Grade Forehead/Underarm Thermometer Device, Medisim, Ltd. (2005) Summary page 1.
- K103839: Behind Ear Gentle Touch Thermometer, Kaz, Inc. (2011) Summary page 1.
- K090386: Non-Invasive Infrared (Nir), Medisim, Ltd. (2010) Summary page 1.

## Indications for use
The UJGFT3 is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the temple (forehead); and/or underarm (axilia); and/or behind the ear as measurement sites.

Source page: https://510kreport.com/device/K131155
Methodology: https://510kreport.com/methodology