# K023456: Oxybox System

- Pathway: 510(k) (Traditional)
- Applicant: Oxyfast Corporation
- Decided: Feb 24, 2003 after 132 days
- Product code: KPJ (Chamber, Oxygen, Topical, Extremity)
- Device class: 2
- Regulation: 21 CFR 878.5650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K831825 (1983). 5 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971507: O2 BOOT, Gwr Medical, Llp (1997) Summary page 1.

## Most influential descendants
- K120764: Epiflo (R) (2012), 1 descendant of its own
- K090681: Tanscu O2 (2009), 1 descendant of its own
- K190742: Epiflo-28 (2019), 0 descendants of its own
- K112634: Natrox Topical Oxygen Delivery System with Iodp (2012), 0 descendants of its own

## Recalls of this device
- Apr 16, 2012 · Not classified · Z-1477-2012: Ogenix Initiated a voluntary recall for the EPIFLO-15 devices due to a mislabeling of the expiry date for this lot. Instead of March 2013, this lot carried May 2013 as the expiry date.
- Mar 24, 2006 · Not classified · Z-1526-06: Conflicting instructions are provided in the Instructions for Use (IFU) and the Clinical Users Guide (CUG) which accompany the EpiFLO device. Consequently, the firm removed the CUG from distribution.

## Indications for use
The OxyBox System is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions, 2) decubitis ulcers, 3) amputation/infected stumps, 4) skin grafts, 5) burns, and 6) frostbite.

Source page: https://510kreport.com/device/K023456
Methodology: https://510kreport.com/methodology