# K081162: Temptouch Dermal Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Diabetica Solutions, Inc.
- Decided: May 8, 2008 after 14 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 K873010 (1987). 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)
- K873010: Surface Temperature Scanner, Omega Medical Corp. (1987) Summary page 1.
- K050137: Temptouch Dermal Thermometer, Xilas Medical, Inc. (2005) Summary page 1.

## 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/K081162
Methodology: https://510kreport.com/methodology