# K183277: SpO2 Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Upnmed Equipment Co., Ltd.
- Decided: May 15, 2019 after 173 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: 2 generations back to K072194 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113727: Shenzhen Med-Link Pulse Oximeter Probe, Shenzhen Med-Link Electronics Tech Co., Ltd. (2013) Summary page 4.

## Indications for use
This SpO2 Sensor is intended for the continuous noninvasive monitoring and spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR, measured by an SpO2 sensor) for use with the finger of adult and pediatric patients. It acts as re-usable accessory of a Patient Monitor.

Source page: https://510kreport.com/device/K183277
Methodology: https://510kreport.com/methodology