# K041694: Digital Flexible Thermometer, Basic Digital Thermometer, Ditital Pacifier Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Hua'An Medical & Health Instruments Co.,
- Decided: Sep 13, 2004 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
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 devices 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.

## Most influential descendants
- K062784: Sejoy Digital Thermometer, MT Series (MT-201, MT-301, MT-402, MT-403 and MT-405) (2007), 11 descendants of its own
- K110776: Digital Thermometer MT Series (2011), 8 descendants of its own
- K153149: Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36 (2016), 7 descendants of its own
- K163518: Digital Thermometer (2017), 6 descendants of its own
- K183393: Digital Thermometer (2019), 4 descendants of its own

## Indications for use
The devices models DT-02 and DT-101 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. The device model NT-01 is an electronic clinical thermometer with pacifier probe head intended to measure oral temperature. The device is reusable for clinical or home use for children under the age of four.

Source page: https://510kreport.com/device/K041694
Methodology: https://510kreport.com/methodology