Cleared Traditional

K140022 - NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT

K140022 is an FDA 510(k) clearance for NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, manufactured by Cork Medical Products, LLC. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K140022 · Cork Medical Products, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
294d
Days
Class 2
Risk

K140022 is an FDA 510(k) clearance for the NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS.... Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Cork Medical Products, LLC (Martinsville, US). The FDA issued a Cleared decision on October 24, 2014 after a review of 294 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.

FDA 510(k) Submission Details - K140022

510(k) Number K140022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2014
Decision Date October 24, 2014
Days to Decision 294 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
179d slower than avg
Panel avg: 115d · This submission: 294d
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 214
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