# K030361: Jasun, Models DT-01F and DT-11F

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Hua'An Medical & Health Instruments Co.,
- Decided: Feb 21, 2003 after 18 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-01F and DT-11F 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/K030361
Methodology: https://510kreport.com/methodology