# K192608: Disposable SpO2 Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Sino-K Medical Technology Co.,Ltd
- Decided: Jan 24, 2020 after 126 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: 19 generations back to K941811 (1994). 83 ancestors in all.
No later device cites it as a predicate yet.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181270: Disposable SpO2 Sensors, Reusable SpO2 Sensors, Orantech, Inc. (2018) Summary page 4.

## Indications for use
The Disposable SPO2 Sensor is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40 kg at hospital facilities.

Source page: https://510kreport.com/device/K192608
Methodology: https://510kreport.com/methodology