# K100488: IR Ear/Forehead Thermometer Mode DX6635, DX6637, DTH1081

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dongdixin Technology Co., Ltd.
- Decided: Jul 22, 2010 after 153 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K010462 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052849: Infrared Thermometer, Fdir-V1, Famidoc Technology Co., Ltd. (2005) Summary page 3.

## Recalls of this device
- Feb 2, 2018 · Class II · Z-0689-2018: Device may provide inaccurate measurements.

## Indications for use
The device is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home.

Source page: https://510kreport.com/device/K100488
Methodology: https://510kreport.com/methodology