# K120566: O2PAK Oxygen Generator

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Precision Products
- Decided: Jul 24, 2012 after 148 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: 3 generations back to K780020 (1978). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052396: Oxysure Portable Oxygen Generator, Model 615, Oxysure Systems, Inc. (2005) Summary page 1.

## Indications for use
The O2PAKTM Portable Oxygen Generator, Model P26029 is intended to provide oxygen for emergency use; the O2PAK TM is currently offered to be used under the Direction of trained medical military personnel in support for disaster relief, crisis response, wartime operations, deterrence and contingency operations, humanitarian relief situations or peacetime engagements.

Source page: https://510kreport.com/device/K120566
Methodology: https://510kreport.com/methodology