# K232678: Digital Thermometer, Model T28, T28L

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Genial Technology Co., Ltd.
- Decided: Jan 31, 2024 after 152 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 digital thermometer is intended for the measurement and monitoring of human body temperature through oral or axillary as the measurement site on people of all ages by doctor or user in the hospital or home.

Source page: https://510kreport.com/device/K232678
Methodology: https://510kreport.com/methodology