# K051566: Proton PHC 8731 10 Second Digital Thermometer; Proton PHC 109 Ear Thermometer; Proton 889 Ear Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Proton Healthcare, Ltd.
- Decided: Jan 17, 2006 after 217 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. The FDA summary names no predicate by number.

## Indications for use
The Proton Thermometer models PHC 8731, PHC 109 and PHC 889 are intended for measuring body temperature of all ages. The Proton Thermometers are reusable and intended for use in the home setting.

Source page: https://510kreport.com/device/K051566
Methodology: https://510kreport.com/methodology