# K201977: TempTraq

- Pathway: 510(k) (Traditional)
- Applicant: Blue Spark Technologies, Inc.
- Decided: Dec 3, 2020 after 140 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.
1 later device descends from it; 1 cites it directly.
0 of 6 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 4.

## Most influential descendants
- K233280: SteadyTemp (2024), 0 descendants of its own

## Indications for use
The Wireless thermometers are battery-operated electronic devices with intended use of measuring human body temperature precisely. The devices are single-use and intended for armpit temperature measurement for persons of all ages.

Source page: https://510kreport.com/device/K201977
Methodology: https://510kreport.com/methodology