# K022028: VX-400 Topical Hyperbaric Oxygen Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Vascular One, Inc.
- Decided: Dec 17, 2002 after 179 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: 2 generations back to K831825 (1983). 5 ancestors in all.
4 later devices descend from it; 2 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.
- K920948: Topical Sacral Hyperbaric Oxygen Chamber, Topox Therapeuutic Rentals, Inc. (1992) Summary page 1.
- (no number) Topical Hyperbaric Oxygen Extremity Chamber: named in the summary without a submission number

## Most influential descendants
- K080966: Hyper-Box Topical Wound Oxygen System (2008), 2 descendants of its own
- K212121: VHT-200 Wound Treatment System (2023), 1 descendant of its own
- K250188: Wound Treatment System (VHT-200) (2025), 0 descendants of its own
- K050156: WHS-1000 Wound Healing System (2005), 0 descendants of its own

## Indications for use
For Treatmeni: of open acute or chronic wounds, e.g., Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions Decubitus ulcers Amputations/infected stumps Skin grafts Burns Frostbite

Source page: https://510kreport.com/device/K022028
Methodology: https://510kreport.com/methodology