# K243000: Reusable Temperature Probe (T1306, T2306, T3306, T4306);  Disposable Temperature Probe (T5106, T6106)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Medke Technology Co., Ltd.
- Decided: Jun 20, 2025 after 267 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 K962070 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121427: Unimed Temperature Probe, Unimed Medical Supplies, Inc. (2012) Summary page 5.

## Indications for use
Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable or for single patient use and designed for use with Mindray monitor Model PM-8000 and other monitors compatible with YSI 400 series temperature probes. These devices are used by qualified medical professional only.

Source page: https://510kreport.com/device/K243000
Methodology: https://510kreport.com/methodology