# K191978: Fever Garde

- Pathway: 510(k) (Traditional)
- Applicant: Hubdic Co., Ltd.
- Decided: Dec 18, 2020 after 513 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: 10 generations back to K010462 (2001). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181013: Fever Scout, VivaLNK, Inc. (2018) Summary page 4.

## Indications for use
The Bluetooth Wearable Thermometer, model HMT-100 is a battery-operated electronic device with an intended use of measuring human armpit temperature and transmitting wireless signal of the measuring results to a mobile device, monitoring armpit body temperature for home use. This product is a non-invasive and re-usable electronic device for multiple patients at home. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.

Source page: https://510kreport.com/device/K191978
Methodology: https://510kreport.com/methodology