Cleared Traditional

K062227 - V.A.C. THERAPY SYSTEM

K062227 is an FDA 510(k) clearance for V.A.C. THERAPY SYSTEM, manufactured by Kci USA, Inc. (Kinetic Concepts, Inc.). The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K062227 · Kci USA, Inc. (Kinetic Concepts, Inc.) · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
63d
Days
Class 2
Risk

K062227 is an FDA 510(k) clearance for the V.A.C. THERAPY SYSTEM. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Kci USA, Inc. (Kinetic Concepts, Inc.) (San Antonio, US). The FDA issued a Cleared decision on October 4, 2006 after a review of 63 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kci USA, Inc. (Kinetic Concepts, Inc.) devices

FDA 510(k) Submission Details - K062227

510(k) Number K062227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2006
Decision Date October 04, 2006
Days to Decision 63 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OMP Device Classification - Class 2, Special Controls

Product Code OMP Negative Pressure Wound Therapy Powered Suction Pump
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
Definition For Wound Management Via Application Of Continual Or Intermittent Negative Pressure To The Wound For Removal Of Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials. The Device Is Indicated For Management Of Chronic, Acute, Traumatic, Subacute And Dehisced Wounds, Partial-thickness Burns, Ulcers (such As Diabetic Or Pressure), Flaps And Grafts.
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 Peers - OMP Negative Pressure Wound Therapy Powered Suction Pump

All 136
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K062227.
V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766
K063740 · Kci USA, Inc. · Jun 2007
V.A.C. FREEDOM CANISTER, MODEL M6275421
K063590 · Kci USA, Inc. · Jan 2007
V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10
K063426 · Kci USA, Inc. · Dec 2006
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
K061788 · Boehringer Laboratories · Jul 2006
MEDELA VARIO SUCTION PUMPS
K061435 · Medela AG · Jun 2006
MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
K053627 · Kci USA, Inc. · Feb 2006