# K090681: Tanscu O2

- Pathway: 510(k) (Abbreviated)
- Applicant: Electrochemical Oxygen Concepts, Inc.
- Decided: Aug 12, 2009 after 149 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: 3 generations back to K831825 (1983). 6 ancestors in all.
1 later device descends from it; 1 cites 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)
- K023456: Oxybox System, Oxyfast Corporation (2003) Summary page 1.

## Most influential descendants
- K112634: Natrox Topical Oxygen Delivery System with Iodp (2012), 0 descendants of its own

## Indications for use
The TransCu 02 low dose tissue oxygenation system is intended for use with wound dressings to treat the following: Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions Pressure ulcers Infected residual limbs Skin grafts Bums Frostbite

Source page: https://510kreport.com/device/K090681
Methodology: https://510kreport.com/methodology