# K162137: Fever Scout™ Continuous Monitoring thermometer

- Pathway: 510(k) (Traditional)
- Applicant: VivaLNK, Inc.
- Decided: Jan 19, 2017 after 171 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: 4 generations back to K003326 (2001). 4 ancestors in all.
29 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143267: TempTraq TT-100, Blue Spark Technologies, Inc. (2015) Summary page 5.

## Most influential descendants
- K181013: Fever Scout (2018), 26 descendants of its own
- K191272: Wearable Device, Wearable Package (2019), 16 descendants of its own
- K210133: Current Health Monitoring System Gen 2 (G2) (2021), 8 descendants of its own
- K221282: Empatica Health Monitoring Platform (2022), 7 descendants of its own
- K230457: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (2023), 4 descendants of its own

## Indications for use
The wireless Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use. 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/K162137
Methodology: https://510kreport.com/methodology