# K223807: Reusable Temperature Probe, Disposable Temperature Probe

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Sino-K Medical Technology Co.,Ltd
- Decided: Aug 25, 2023 after 248 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 K962070 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193338: Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes, Shenzhen Med-Link Electronics Tech Co., Ltd. (2020) Summary page 4.

## Indications for use
Reusable Temperature Probes: Reusable Temperature Probes are intended to be used for monitoring temperature for multi-patient use. The temperature probes are reusable and designed for use with monitor of GE-Marquette Model DASH3000. These devices are used by qualified medical professionals only. Disposable Temperature Probes: Disposable Temperature Probes are intended to be used for monitoring temperature for single patient use. The temperature probes are non-sterile and designed for use with monitors of GE-Marquette Model DASH3000. These devices are used by qualified medical professionals only.

Source page: https://510kreport.com/device/K223807
Methodology: https://510kreport.com/methodology