Cleared Traditional

K050261 - V.A.C. GRANUFOAM SILVER PROTECTION DRESSING

K050261 is an FDA 510(k) clearance for V.A.C. GRANUFOAM SILVER PROTECTION DRESSING, manufactured by 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 111-day FDA review.

K050261 · Kinetic Concepts, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
111d
Days
Class 2
Risk

K050261 is an FDA 510(k) clearance for the V.A.C. GRANUFOAM SILVER PROTECTION DRESSING. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Kinetic Concepts, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 26, 2005 after a review of 111 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Kinetic Concepts, Inc. devices

FDA 510(k) Submission Details - K050261

510(k) Number K050261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2005
Decision Date May 26, 2005
Days to Decision 111 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
4d faster than avg
Panel avg: 115d · This submission: 111d
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 135
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K050261.
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
V.A.C. GRANUFOAM SILVER DRESSING
K041642 · Kinetic Concepts, Inc. · Jan 2005
MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS
K032310 · Kinetic Concepts, Inc. · Oct 2003
VACUUM ASSISTED CLOSURE
K021500 · Kinetic Concepts, Inc. · Dec 2002