Cleared Traditional

K122490 - KULAVAC

K122490 is an FDA 510(k) clearance for KULAVAC, manufactured by CG Bio Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 455-day FDA review.

K122490 · CG Bio Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2013
Decision
455d
Days
Class 2
Risk

K122490 is an FDA 510(k) clearance for the KULAVAC. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by CG Bio Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on November 13, 2013 after a review of 455 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all CG Bio Co., Ltd. devices

FDA 510(k) Submission Details - K122490

510(k) Number K122490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2012
Decision Date November 13, 2013
Days to Decision 455 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
340d slower than avg
Panel avg: 115d · This submission: 455d
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 K122490.
INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K141926 · Medela AG · Dec 2014
V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS
K133276 · Kci USA, Inc. · Nov 2013
V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K132741 · Kci USA, Inc. · Nov 2013
RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE
K132446 · Smith & Nephew, Inc. · Oct 2013
KCI NPWT GAUZE DRESSING
K123507 · Kci USA, Inc. · Apr 2013
INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K113678 · Medela AG · Oct 2012