# K233280: SteadyTemp

- Pathway: 510(k) (Traditional)
- Applicant: Steadysense GmbH
- Decided: Jun 21, 2024 after 266 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: 5 generations back to K003326 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201977: TempTraq, Blue Spark Technologies, Inc. (2020) Summary page 5.

## Indications for use
The SteadyTemp system is a wireless thermometer intended to provide precise body temperature for users of all ages. The SteadyTemp system comprises a single-use temperature measuring sensor, the SteadySense Patch, and the SteadyTemp application. SteadySense Patch measures and stores axillary skin temperature data up to 10 days. The typical application duration when using the system is 7 days.

Source page: https://510kreport.com/device/K233280
Methodology: https://510kreport.com/methodology