# K991569: Home/Commercial Oxygen Unit by System O2

- Pathway: 510(k) (Traditional)
- Applicant: 02 Marketing Group, Inc.
- Decided: Aug 3, 1999 after 90 days
- Product code: CAW (Generator, Oxygen, Portable)
- Device class: 2
- Regulation: 21 CFR 868.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- May 1, 2003 · Not classified · Z-0929-03: System O2 oxygen flow rate found to be inadequate and RejuvO2 Home Oxygen Bar contains 'Adulterated Labeling.'

## Indications for use
The Home/Commercial Oxygen Unit by system O2™ is intended to provide oxygen for emergency first aid. The Home/Commercial Oxygen Unit by system O2™ delivers in excess of 5 liters per minute for more than 15 minutes. Because the unit does not yet exceed 6 liters per minute average flow rate, the packaging will include the following statement: CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a licensed physician.

Source page: https://510kreport.com/device/K991569
Methodology: https://510kreport.com/methodology