Cleared Traditional

K032301 - NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900

K032301 is an FDA 510(k) clearance for NEOGEN ONE, manufactured by Neogen Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K032301 · Neogen Technologies, Inc. · General & Plastic Surgery device
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Aug 2003
Decision
27d
Days
Class 2
Risk

K032301 is an FDA 510(k) clearance for the NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Neogen Technologies, Inc. (Ft Lauderdale, US). The FDA issued a Cleared decision on August 21, 2003 after a review of 27 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 Neogen Technologies, Inc. devices

FDA 510(k) Submission Details - K032301

510(k) Number K032301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2003
Decision Date August 21, 2003
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
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 177
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K032301.
V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
K050261 · Kinetic Concepts, Inc. · May 2005
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
V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT
K021501 · Kinetic Concepts, Inc. · Dec 2002
V.A.C. PLUS
K992448 · Kinetic Concepts, Inc. · Jan 2000