# K172981: Reusable SpO2 Sensors, Disposable SpO2 Sensors

- Pathway: 510(k) (Traditional)
- Applicant: APK Technology Co., Ltd.
- Decided: Jun 8, 2018 after 254 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.

## Indications for use
The devices are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive oximeter equipment. The sensors are reusable or disposable depending on models, and are intended for adult, pediatric or infant, depending on models. They shall be used in healthcare settings.

Source page: https://510kreport.com/device/K172981
Methodology: https://510kreport.com/methodology