# K182667: Med-link Temperature Probes

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Med-Link Electronics Tech Co., Ltd.
- Decided: Jun 18, 2019 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: 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
Med-link Temperature Probes are intended to be used for monitoring temperature for multi-patient use. The temperature probes are reusable and designed for use with monitors of Philips Model IntelliVue MP50, Mindray Model PM-9000, Datex-Ohmeda Model Cardiocap II, Drager Model Infinity Gamma XL. These devices are used by qualified medical professional only.

Source page: https://510kreport.com/device/K182667
Methodology: https://510kreport.com/methodology