# K230889: Digital Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Wenzhou Yosun Medical Technology Co.,Ltd
- Decided: Apr 3, 2024 after 369 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 to measure body temperature orally, rectally and under the arm (armpit). The devices are reusable in a clinical or home use setting on people of all ages, including children under the age of 8 with adult supervision.

Source page: https://510kreport.com/device/K230889
Methodology: https://510kreport.com/methodology