# K082846: Apk SPO2 Pulse Oximeter Sensor

- Pathway: 510(k) (Traditional)
- Applicant: APK Technology Co., Ltd.
- Decided: Apr 3, 2009 after 186 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: 1 generation back to K002223 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002223: Epic SPO2 Finger Sensor, Model E412-20, Epic Medical Equipment Services, Inc. (2000) Summary page 2.

## Indications for use
The APK SpO2 Pulse Oximeter sensor (Reusable) is intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive with oximeter equipment, which are intended for adult or pediatric patients (more than 5kg) in hospitals, hospital-type facilities, and home environments. The APK SpO2 Pulse Oximeter sensor (Disposable) is intended for single use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are adults or pediatric patients (more than 5kg) in hospitals, hospital-type facilities, and home environments.

Source page: https://510kreport.com/device/K082846
Methodology: https://510kreport.com/methodology