Cleared Special

Wound Treatment System (VHT-200)

K250188 · Vaporox, Inc. · General & Plastic Surgery
Mar 2025
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K250188 is an FDA 510(k) clearance for the Wound Treatment System (VHT-200), a Chamber, Oxygen, Topical, Extremity (Class II — Special Controls, product code KPJ), submitted by Vaporox, Inc. (Centennial, US). The FDA issued a Cleared decision on March 10, 2025, 47 days after receiving the submission on January 22, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5650.

Submission Details

510(k) Number K250188 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2025
Decision Date March 10, 2025
Days to Decision 47 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KPJ — Chamber, Oxygen, Topical, Extremity
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5650