# K122912: Digital Thermometer (with Disposable Thermometer Cover)

- Pathway: 510(k) (Special)
- Applicant: Hangzhou Hua'An Medical & Health Instruments Co.,
- Decided: Nov 7, 2012 after 47 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 devices models DT-K1 1B, DT-Ki 116B, DT-K1 lI D, DT-1 lI D, DT-1 11 G, OT- I G, DT-Y1 11 D are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.

Source page: https://510kreport.com/device/K122912
Methodology: https://510kreport.com/methodology