Cleared Traditional

K212121 - VHT-200 Wound Treatment System

K212121 is an FDA 510(k) clearance for VHT-200 Wound Treatment System, manufactured by Vaporox, Inc.. The device is a Class 2 General & Plastic Surgery device with product code KPJ cleared through the Traditional 510(k) pathway after a 624-day FDA review.

K212121 · Vaporox, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
624d
Days
Class 2
Risk

K212121 is an FDA 510(k) clearance for the VHT-200 Wound Treatment System. Classified as Chamber, Oxygen, Topical, Extremity (product code KPJ), Class II - Special Controls.

Submitted by Vaporox, Inc. (Centennial, US). The FDA issued a Cleared decision on March 23, 2023 after a review of 624 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5650 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Vaporox, Inc. devices

FDA 510(k) Submission Details - K212121

510(k) Number K212121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2021
Decision Date March 23, 2023
Days to Decision 624 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
509d slower than avg
Panel avg: 115d · This submission: 624d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPJ Device Classification - Class 2, Special Controls

Product Code KPJ Chamber, Oxygen, Topical, Extremity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Hyman, Phelps & McNamara, P.C.
Allyson B. Mullen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPJ Chamber, Oxygen, Topical, Extremity

Devices cleared under the same product code (KPJ) and FDA review panel - the closest regulatory comparables to K212121.
Wound Treatment System (VHT-200)
K250188 · Vaporox, Inc. · Mar 2025
EPIFLO-28
K190742 · Neogenix, LLC Dba Ogenix · Dec 2019
O2 CARE
K882461 · Ballard Medical Products · Nov 1988
DISPOSABLE, HYPERBARIC OXYGEN CHAMBER
K840817 · Hospitak, Inc. · Apr 1984
DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM
K831825 · Hospitak, Inc. · Oct 1983