# K051251: Infrared Ear Themometer, Models DX6603, DX66390

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dongdixin Technology Co., Ltd.
- Decided: Sep 7, 2005 after 114 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in neonatal, pediatric and adult population used in the home setting.

Source page: https://510kreport.com/device/K051251
Methodology: https://510kreport.com/methodology