# K982243: Canogen Portable Oxygen Generator Model 615

- Pathway: 510(k) (Traditional)
- Applicant: Canogen International, Ltd.
- Decided: Nov 19, 1998 after 147 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: 1 generation back to K780020 (1978). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K780020: Generator, Oxygen, Portable, Jet Research Center, Inc. (1978) Summary page 1.

## Most influential descendants
- K052396: Oxysure Portable Oxygen Generator, Model 615 (2005), 5 descendants of its own
- K062153: Portable Oxygen Generator System (2006), 2 descendants of its own
- K131016: ROGS (2013), 1 descendant of its own
- K240561: Rugged Oxygen Generator  (ROG) (RO01-00001) (2024), 0 descendants of its own
- K120566: O2PAK Oxygen Generator (2012), 0 descendants of its own

## Indications for use
The Canogen Portable Oxygen Generator, Model 615 is intended to produce oxygen for emergency use.

Source page: https://510kreport.com/device/K982243
Methodology: https://510kreport.com/methodology