Cleared Traditional

K121883 - PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT

K121883 is an FDA 510(k) clearance for PREVENA INCISION MANAGEMENT SYSTEM WITH..., manufactured by Kci USA, Inc. (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 105-day FDA review.

K121883 · Kci USA, Inc. (Kinetic Concepts, Inc.) · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
105d
Days
Class 2
Risk

K121883 is an FDA 510(k) clearance for the PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOM.... Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Kci USA, Inc. (Kinetic Concepts, Inc.) (San Antonio, US). The FDA issued a Cleared decision on October 11, 2012 after a review of 105 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 Kci USA, Inc. (Kinetic Concepts, Inc.) devices

FDA 510(k) Submission Details - K121883

510(k) Number K121883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2012
Decision Date October 11, 2012
Days to Decision 105 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
10d faster than avg
Panel avg: 115d · This submission: 105d
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
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K121883.
AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM
K122132 · Molnlycke Health Care · Jan 2013
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING
K123878 · Kci USA, Inc. (Kinetic Concepts, Inc.) · Jan 2013
VOLTERA POWERED SUCTION PUMP
K112853 · Suzric Enterprise Co., Ltd. · Nov 2012
ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM
K120499 · Kci USA, Inc. (Kinetic Concepts, Inc.) · Oct 2012
INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K113678 · Medela AG · Oct 2012
SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300
K113291 · Simex Medizintechnik GmbH · Aug 2012