# K212121: VHT-200 Wound Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Vaporox, Inc.
- Decided: Mar 23, 2023 after 624 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). 8 ancestors in all.
1 later device descends 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)
- K080966: Hyper-Box Topical Wound Oxygen System, Aoti, Ltd. (2008) Summary page 4.

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

## Indications for use
The intended use of VHT 200 wound treatment system is to provide humidified oxygen to open, acute or chronic wounds as an adjunct therapy in wound management and treatment. The VHT-200 wound treatment system is intended for the following kinds of wounds: • skin ulcerations due to diabetes, venous stasis, and post-surgical infections, and gangrenous lesions • decubitus ulcers • amputations/infected stumps • skin grafts • burns • frostbite

Source page: https://510kreport.com/device/K212121
Methodology: https://510kreport.com/methodology