# K193338: Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Med-Link Electronics Tech Co., Ltd.
- Decided: Aug 25, 2020 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: 4 generations back to K962070 (1996). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 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.
- K181967: Disposable Temperature Probe, Shenzhen Launch Electrical Co., Ltd. (2018) Summary page 5.

## Most influential descendants
- K223807: Reusable Temperature Probe, Disposable Temperature Probe (2023), 0 descendants of its own

## Indications for use
Med-link Reusable Temperature Probes: 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 IntelliVueMP50, Mindray Model PM-9000 and Drager Model Infinity Gamma XL. These devices are used by qualified medical professional only. Med-link Disposable Temperature Probes: Med-link 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 Model B20 and Philips Model IntelliVueMP50. These devices are used by qualified medical professional only.

Source page: https://510kreport.com/device/K193338
Methodology: https://510kreport.com/methodology