# K230702: Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)

- Pathway: 510(k) (Traditional)
- Applicant: Qingdao Kingon Medical Science and Technology Co., Ltd.
- Decided: Oct 18, 2023 after 218 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K020324 (2002). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210371: Portable Oxygen Concentrator, model: P2-E6, Qingdao Kingon Medical Science and Technology Co., Ltd. (2022) Summary page 8.

## Most influential descendants
- K242718: Portable Oxygen Concentrator (P2-TOC) (2025), 1 descendant of its own
- K252268: V series portable oxygen concentrator (V5, V5C, V6, V6C) (2025), 0 descendants of its own
- K242736: Portable Oxygen Concentrator (Spirit-3) (2025), 0 descendants of its own

## Indications for use
The Portable Oxygen Concentrator (Model: P2-K4,P2-K3,P2-S4, P2-S3) is intended to provide supplemental oxygen in a home, institutional, or travel environment. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Portable Oxygen Concentrator(Model:P2-K4,P2-K3,P2-S4,P2-S3) is small, portable and may be used in home, institution and various mobile environments. However, there is not any type of humidifier that is suitable for use with this device because of its pulse dose delivery mode.

Source page: https://510kreport.com/device/K230702
Methodology: https://510kreport.com/methodology