# K050137: Temptouch Dermal Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Xilas Medical, Inc.
- Decided: Mar 18, 2005 after 53 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K081162: Temptouch Dermal Thermometer (2008), 0 descendants of its own

## Indications for use
The TempTouch® Dermal Thermometer is an infrared thermometer intended for the intermittent measurement of skin surface temperature of people of all ages.

Source page: https://510kreport.com/device/K050137
Methodology: https://510kreport.com/methodology