# K161211: Digital Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Biocare Asia Corporation, Ltd.
- Decided: Aug 29, 2016 after 123 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 K881446 (1988). 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)
- K133111: Kingtech Digital Thermometer, Kingtech Enterprise, Ltd. (2013) Summary page 4.

## Indications for use
Digital Thermometer is intended to measure body temperature in axillary, oral or rectum and to be used by medical professionals in clinical and hospital environments or consumers in a home environment. It is intended for use on people of all ages.

Source page: https://510kreport.com/device/K161211
Methodology: https://510kreport.com/methodology