# K113727: Shenzhen Med-Link Pulse Oximeter Probe

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Med-Link Electronics Tech Co., Ltd.
- Decided: Mar 21, 2013 after 458 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K072194 (2007). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072194: Renu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25, Renu Medical, Inc. (2007) Summary page 1.

## Most influential descendants
- K183277: SpO2 Sensor (2019), 0 descendants of its own

## Indications for use
Shenzhen Med-link disposable probe, model S0136J-L, is indicated for single patient use when continuous, non-Invasive arterial oxygen saturation and pulse rate monitoring are required for adult patients or pediatric patients weighing more than 30 kg. The S0136J-L is contraindicated for use with patients during motion condition.

Source page: https://510kreport.com/device/K113727
Methodology: https://510kreport.com/methodology