# K143267: TempTraq TT-100

- Pathway: 510(k) (Traditional)
- Applicant: Blue Spark Technologies, Inc.
- Decided: Sep 2, 2015 after 293 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: 3 generations back to K003326 (2001). 3 ancestors in all.
32 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063542: Wireless Temperature Monitor / Models ST323C and ST323F., Mesure Technology Co., Ltd. (2007) Summary page 6.

## Most influential descendants
- K162137: Fever Scout™ Continuous Monitoring thermometer (2017), 29 descendants of its own
- 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

## Indications for use
The Wireless thermometer, model TT-100, is a battery-operated electronic device with intended use of measuring human body temperature precisely. This device is single-use and intended for armpit temperature measurement for persons of all age.

Source page: https://510kreport.com/device/K143267
Methodology: https://510kreport.com/methodology