# K183393: Digital Thermometer

- Pathway: 510(k) (Traditional)
- Applicant: Joytech Healthcare Co., Ltd.
- Decided: Nov 18, 2019 after 346 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
Longest line of descent: 5 generations back to K902624 (1990). 8 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163518: Digital Thermometer, Joytech Healthcare Co., Ltd. (2017) Summary page 5.

## Most influential descendants
- K200599: Digital Thermometer (2020), 2 descendants of its own
- K223044: Digital Thermometer (Model QT001) (2023), 1 descendant of its own
- K240109: Medical electronic thermometer (FC01, FC02) (2024), 0 descendants of its own
- K213485: Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E (2022), 0 descendants of its own

## Indications for use
The Digital Thermometers DMT series(Except DMT-455) are intended to measure the human body temperature in regular mode orally, rectally or under the arm. And the devices are reusable for clinical or home use on people of all ages, including children under 8 with adult supervision. The device model DMT-455 is intended to measure temperature orally, and the device is reusable for clinical or home use for children less than 4 years old with adult supervision.

Source page: https://510kreport.com/device/K183393
Methodology: https://510kreport.com/methodology