# K052396: Oxysure Portable Oxygen Generator, Model 615

- Pathway: 510(k) (Traditional)
- Applicant: Oxysure Systems, Inc.
- Decided: Dec 9, 2005 after 100 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
Longest line of descent: 2 generations back to K780020 (1978). 2 ancestors in all.
5 later devices descend from it; 3 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)
- K982243: Canogen Portable Oxygen Generator Model 615, Canogen International, Ltd. (1998) Summary page 1.

## Most influential descendants
- 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
- K102750: O2-in-a-Box, O2-in-a-Box (2011), 0 descendants of its own

## Recalls of this device
- Jun 12, 2015 · Class II · Z-2253-2015: Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for a minimum of 15 minutes.

## Indications for use
The OxySure TM System is intended to produce oxygen for emergency use.

Source page: https://510kreport.com/device/K052396
Methodology: https://510kreport.com/methodology