# K080966: Hyper-Box Topical Wound Oxygen System

- Pathway: 510(k) (Traditional)
- Applicant: Aoti, Ltd.
- Decided: Aug 6, 2008 after 124 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). 7 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K022028: VX-400 Topical Hyperbaric Oxygen Chamber, Vascular One, Inc. (2002) Summary page 1.
- K971507: O2 BOOT, Gwr Medical, Llp (1997) Summary page 1.
- K020466: HEC 1000, Metro Medical Equipment, Inc. (2002) Summary page 1.
- (no number) Advanced Hyperbaric Technologies Inc. Topical Hyperbaric Oxygen Extremity Chamber: named in the summary without a submission number

## Most influential descendants
- K212121: VHT-200 Wound Treatment System (2023), 1 descendant of its own
- K250188: Wound Treatment System (VHT-200) (2025), 0 descendants of its own

## Indications for use
The AOTI Hyper-Box Topical Wound Oxygen System is intended to be used for the treatment of open acute or chronic wounds, such as; o skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions o decubitus ulcers o amputations/infected stumps o skin grafts o bums o frostbite

Source page: https://510kreport.com/device/K080966
Methodology: https://510kreport.com/methodology