# K250188: Wound Treatment System (VHT-200)

- Pathway: 510(k) (Special)
- Applicant: Vaporox, Inc.
- Decided: Mar 10, 2025 after 47 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: 5 generations back to K831825 (1983). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212121: VHT-200 Wound Treatment System, Vaporox, Inc. (2023) Summary page 5.

## Indications for use
VHT-200 is intended to provide ultrasonically generated mist and concentrated oxygen to open, acute and chronic wounds as an adjunct therapy in wound management and treatment. The VHT-200 is intended for the following kinds of wounds: • Skin ulcerations due to diabetes, venous stasis, and post-surgical infections • Gangrenous lesions • Decubitus ulcers • Amputations / infected stumps • Skin grafts • Burns • Frostbite

Source page: https://510kreport.com/device/K250188
Methodology: https://510kreport.com/methodology