Cleared Traditional

K162159 - VCare 1000-300S Pump

K162159 is an FDA 510(k) clearance for VCare 1000-300S Pump, manufactured by Vr Medical Technologies, LLC. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K162159 · Vr Medical Technologies, LLC · General & Plastic Surgery device
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Apr 2017
Decision
269d
Days
Class 2
Risk

K162159 is an FDA 510(k) clearance for the VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Vr Medical Technologies, LLC (Kunshan, CN). The FDA issued a Cleared decision on April 28, 2017 after a review of 269 days - an extended review 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: 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 Vr Medical Technologies, LLC devices

FDA 510(k) Submission Details - K162159

510(k) Number K162159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2016
Decision Date April 28, 2017
Days to Decision 269 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
154d slower than avg
Panel avg: 115d · This submission: 269d
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 147
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K162159.
Occlusion Detection Dressing Kit
K171499 · Cardinalhealth · Sep 2017
PICO Single Use Negative Pressure Wound Therapy System
K172521 · Smith & Nephew Medical Limited · Sep 2017
PICO Single Use Negative Pressure Wound Therapy System
K172519 · Smith & Nephew Medical Limited · Sep 2017
PICO Single Use Negative Pressure Wound Therapy System
K163387 · Smith & Nephew Medical Limited · Apr 2017
UNO Negative Pressure Wound Therapy System
K161599 · Genadyne Biotechnologies, Inc. · Apr 2017
Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film
K170088 · Medela AG · Apr 2017