# K200069: Disposable SpO2 Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Changke Connect Electronics Co., Ltd.
- Decided: Mar 13, 2020 after 60 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). 87 ancestors in all.
No later device cites it as a predicate yet.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191279: Disposable SpO2 Sensor, Shenzhen Caremed Medical Technology Co., Ltd. (2019) 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 adults in hospital environment.

Source page: https://510kreport.com/device/K200069
Methodology: https://510kreport.com/methodology