# K173368: Reusable & Disposable SpO2 Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Coreray Technology, Ltd.
- Decided: Aug 31, 2018 after 309 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: 18 generations back to K941811 (1994). 82 ancestors in all.
No later device cites it as a predicate yet.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153184: Caremed Reusable & Disposable SPO2 Sensors, Shenzhen Caremed Medical Technology Co., Ltd. (2017) Summary page 5.
- K100077: Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103, Solaris Medical Technology, Inc. (2010) Summary page 5.

## Indications for use
Coreray Reusable SPO2 Sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel. The Reusable SPO2 Sensor is intended for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40kg.

Source page: https://510kreport.com/device/K173368
Methodology: https://510kreport.com/methodology