# K181013: Fever Scout

- Pathway: 510(k) (Traditional)
- Applicant: VivaLNK, Inc.
- Decided: Aug 21, 2018 after 126 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: 9 generations back to K010462 (2001). 15 ancestors in all.
26 later devices descend from it; 6 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162137: Fever Scout™ Continuous Monitoring thermometer, VivaLNK, Inc. (2017) Summary page 4.
- K160306: Cloud Smart Thermometer, Guangzhou Bosma Technology Co, Ltd. (2016) Summary page 5.

## Most influential descendants
- 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
- K203208: Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System (2022), 3 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 and a non-invasive and single patient use in the hospital. 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/K181013
Methodology: https://510kreport.com/methodology