# K112634: Natrox Topical Oxygen Delivery System with Iodp

- Pathway: 510(k) (Traditional)
- Applicant: Inotec Amd, Ltd.
- Decided: Jul 3, 2012 after 298 days
- Product code: KPJ (Chamber, Oxygen, Topical, Extremity)
- Device class: 2
- Regulation: 21 CFR 878.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K831825 (1983). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023456: Oxybox System, Oxyfast Corporation (2003) Summary page 1.
- K090681: Tanscu O2, Electrochemical Oxygen Concepts, Inc. (2009) Summary page 1.

## Indications for use
The NATROX System is a low-dose tissue oxygenation system intended to provide topical oxygen to aid in the healing of chronic wounds such as: * Skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions, * Decubitis ulcers (bedsores), * Amputations/infected stumps, * Skin grafts, * Bums, and * Frostbite

Source page: https://510kreport.com/device/K112634
Methodology: https://510kreport.com/methodology