# K160358: DT-100

- Pathway: 510(k) (Traditional)
- Applicant: Mediana Co., Ltd.
- Decided: Feb 24, 2017 after 381 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 K010462 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101736: Non-Contact Forehead Infrared Thermometer, Model DT-8806H, Body Infrared Thermometer, Model DT-8806 and Digital Infrared, Shenzhen Everbest Machinery Industry Co., Ltd. (2010) Summary page 4.

## Indications for use
The DT-100 non-contact infrared thermometer is intended to be used to measure the body temperature using infrared sensors. It can detect the body temperature of all ages from human’s face. The DT-100 infrared thermometer can be used by consumers in household environment.

Source page: https://510kreport.com/device/K160358
Methodology: https://510kreport.com/methodology