# K203643: Sensatronic Reusable Temperature Probes

- Pathway: 510(k) (Traditional)
- Applicant: Sensatronic GmbH
- Decided: Aug 11, 2021 after 240 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: 2 generations back to K962070 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050837: Reusable Temperature Probes (M1024254 Skin Temperature Probe, Reusable; M1024247, GP Temperature Probe, Adult, Resuable, GE Healthcare (2005) Summary page 4.

## Indications for use
Sensatronic Reusable Temperature Probes are intended to be used for monitoring temperature. The temperature probes are designed for use with GE Healthcare monitoring systems, Schiller and other monitors compatible with YSI 400 Series temperature probes. The probes are indicated for use by qualified medical personnel only.

Source page: https://510kreport.com/device/K203643
Methodology: https://510kreport.com/methodology