# K080243: Portable Oxygen Unit SCA900

- Pathway: 510(k) (Traditional)
- Applicant: San Cheong Co., Ltd.
- Decided: Apr 7, 2009 after 432 days
- Product code: CAN (Regulator, Pressure, Gas Cylinder)
- Device class: 1
- Regulation: 21 CFR 868.2700
- 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 K963247 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061785: Cyl-Fil Oxygen System, Responsive Respiratory, Inc. (2006) Summary page 2.
- K053117: EZ-OX Plus, Air Liquide Healthcare America (2006) Summary page 2.
- K063354: Linde Integrated Valve (Liv), Linde Gas Therapeutics (2007) Summary page 2.

## Indications for use
The Portable Oxygen Unit SCA900 is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults; a pressure regulator, flow meter and oxygen cylinder fully integrated into single unit. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and'rolling.

Source page: https://510kreport.com/device/K080243
Methodology: https://510kreport.com/methodology