Prevena Incision Management System with Customizable Dressing, Prevena Customizable Dressing Kit
FDA 510(k) K121883 · Kci USA, Inc. (Kinetic Concepts, Inc.)
Submission
- Device name
- Prevena Incision Management System with Customizable Dressing, Prevena Customizable Dressing Kit
- Applicant
- Kci USA, Inc. (Kinetic Concepts, Inc.)
San Antonio, TX, US - Received
- June 28, 2012
- Decision date
- October 11, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
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.
Other 510(k)s with product code OMP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261338 | RENASYS DYNAFLOW Kit (66807741)OMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2026SE |
| K253263 | ConvaVAC Negative Pressure Wound Therapy SystemOMP · Traditional | Convatec Limited, Gdc Building | 06/24/2026SE |
| K253199 | Curasys 2 (EMDN0003)OMP · Traditional | CG Bio Co., Ltd. | 06/23/2026SE |
| K260646 | Renasys Edge (66803126)OMP · Traditional | Smith & Nephew Medical, Ltd. | 05/27/2026SE |
| K261291 | Nisus NPWT Canister 500-mL (CPC-500)OMP · Special | Cork Medical | 05/21/2026SE |
| K254019 | Wound Geni NPWT SystemOMP · Traditional | Bechtel Medical, Inc. | 05/04/2026SE |
| K253429 | Genadyne ASTRA NPWTOMP · Traditional | Genadyne Biotechnologies, Inc. | 03/12/2026SE |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…OMP · Traditional | Deroyal Industries, Inc. | 11/21/2025SE |
| K251646 | extriCARE® 1000 Negative Pressure Wound Therapy SystemOMP · Traditional | Alleva Medical Devices | 10/03/2025SE |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologyOMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2025SE |
More from Smith & Nephew Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K162790 | V.A.C.ULTA Negative Pressure Wound Therapy SystemOMP · Traditional | 01/26/2017SE |
| K161897 | PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsOMP · Traditional | 10/04/2016SE |
| K160451 | V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...OMP · Traditional | 06/20/2016SE |
| K141017 | Prevena Incision Management System with Peel & Dressing, Prevena Incision Management…OMP · Traditional | 08/20/2015SE |
| K133232 | Prevena Incision Management System with Customizable Dressing, Prevena Incision…OMP · Traditional | 03/24/2014SE |
| K123878 | Prevena Incision Management System with Customizable DressingOMP · Special | 01/15/2013SE |
| K120499 | Abthera Open Abdomen Negative Pressure Therapy SystemOMP · Traditional | 10/05/2012SE |
| K103156 | V.A.C. Veraflo Cleanse Dressing SystemOMP · Special | 03/14/2011SE |
| K102956 | V.A.C. Granufoam Silver Small Dressing; V.A.C. Granufoam Silver Medium Dressing; V.A.C.…OMP · Special | 12/15/2010SE |
| K100657 | V.A.C. Ulta Negative Pressure Wound Therapy System (V.A.C. Ulta Therapy System) Model…OMP · Traditional | 09/17/2010SE |
Questions and answers
When was Prevena Incision Management System with Customizable Dressing, Prevena Customizable Dressing Kit cleared by the FDA?
Prevena Incision Management System with Customizable Dressing, Prevena Customizable Dressing Kit (K121883) received a 510(k) decision of Substantially Equivalent on October 11, 2012, 105 days after the submission was received.
What is the product code of K121883?
The FDA product code is OMP – Negative Pressure Wound Therapy Powered Suction Pump, a Class II (moderate risk) device regulated under 21 CFR 878.4780.