# K102718: Digital Thermometer; Digital Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: International Regulatory Consultants, LLC (Irc)
- Decided: Dec 13, 2010 after 83 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: 3 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)
- K101043: Ect Digital Thermometer, Changshan Estar Electronics Co., Ltd. (2010) Summary page 1.

## Indications for use
To measure the human body temperature in regular mode orally, rectally or underarm. The devices are reusable for clinical or home use on people of all ages.

Source page: https://510kreport.com/device/K102718
Methodology: https://510kreport.com/methodology