# K051422: Dual Mode UP-Grade Forehead/Underarm Thermometer Device

- Pathway: 510(k) (Special)
- Applicant: Medisim, Ltd.
- Decided: Sep 1, 2005 after 92 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: 3 generations back to K902624 (1990). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032362: UP-Grade Forehead Thermometer, Medisim, Ltd. (2003) Summary page 2.
- K012217: M5T Instant Fever Thermometer, Medisim, Ltd. (2001) Summary page 2.

## Most influential descendants
- K131155: UGFT3; FHT7 (2013), 0 descendants of its own

## Indications for use
The Dual Mode Up-Grade Forehead/ Underarm Thermometer device is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the forehead and axilla as measurement sites..

Source page: https://510kreport.com/device/K051422
Methodology: https://510kreport.com/methodology