Negative Pressure Wound Therapy Powered Suction Pump
FDA product code OMP · Class II (moderate risk) · 21 CFR 878.4780 · 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.
215510(k) clearances
0PMA approvals
47recalls
Manufacturers
- Kci USA, Inc. 26
- Smith & Nephew Medical Limited 21
- Genadyne Biotechnologies, Inc. 16
- Smith & Nephew, Inc. 14
- Medela AG 13
- Kci USA, Inc. (Kinetic Concepts, Inc.) 13
- Kinetic Concepts, Inc. 7
- Cardinalhealth 7
- Molnlycke Health Care Us, LLC 7
- 3M Healthcare Business Group 4
- Devon Medical, Inc. 4
- Cork Medical 4
- Innovative Therapies, Inc. 4
- Blue Sky Medical Group Incorporated 4
- Carilex Medical, Inc. 4
- Applied Tissue Technologies, LLC 3
- Zhejiang Longterm Medical Technology Co., Ltd. 3
- Devon Medical Products 3
- Talley Group, Ltd. 2
- Talley Medical 2
510(k) clearances
| 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 |
| K243187 | Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)OMP · Traditional | Cork Medical | 06/27/2025SE |
| K243576 | RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze…OMP · Traditional | Smith & Nephew Medical, Ltd. | 02/18/2025SE |
| K233614 | Genadyne DUO NPWTOMP · Traditional | Genadyne Biotechnologies, Inc. | 12/23/2024SE |
| K241061 | VERSA Negative Pressure Wound Therapy System (VCMPP-100)OMP · Traditional | Cork Medical | 08/21/2024SE |
| K241023 | Negative Pressure Wound Therapy Device (V-Move, V-Grand)OMP · Traditional | Med Way, Inc. | 08/19/2024SE |
| K241515 | NEXA NPWT SystemOMP · Traditional | Nexa Medical Limited | 07/26/2024SE |
| K231939 | Renasys EdgeOMP · Traditional | Smith & Nephew Medical, Ltd. | 05/24/2024SE |
| K241134 | 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10)OMP · Special | Kci USA, Inc. | 05/23/2024SE |
| K230233 | Prospera Spectruum Negative Pressure Wound Therapy SystemOMP · Traditional | Deroyal Industries, Inc. | 04/18/2024SE |
| K231646 | Carilex VT¿200-i NXOMP · Traditional | Carilex Medical, Inc. | 04/17/2024SE |
| K232379 | PREVENT KitOMP · Traditional | Clear Choice Therapeutics | 02/05/2024SE |
| K230677 | Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)OMP · Traditional | Cork Medical | 12/06/2023SE |
| K223388 | Invia® Integrated DressingOMP · Traditional | Medela AG | 07/07/2023SE |
| K221888 | Genadyne Hybrid Foam DressingsOMP · Traditional | Genadyne Biotechnologies, Inc. | 06/12/2023SE |
| K222859 | 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place…OMP · Traditional | 3M | 03/23/2023SE |
| K221585 | 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete…OMP · Traditional | 3M Healthcare Business Group | 03/23/2023SE |
| K213906 | extriCARE 1000 Negative Pressure Wound Therapy SystemOMP · Traditional | Alleva Medical, Ltd. | 03/08/2023SE |
| K213853 | RENASYS-WF White Foam NPWT Dressing Small; RENASYS-WF White Foam NPWT Dressing LargeOMP · Traditional | Smith and Nephew Medical Limited | 02/10/2023SE |
| K221223 | extriCARE® 3000 Negative Wound Pressure Therapy SystemOMP · Traditional | Alleva Medical Devices | 02/09/2023SE |
| K221891 | UNO Negative Pressure Wound Therapy SystemOMP · Special | Genadyne Biotechnologies, Inc. | 12/14/2022SE |
| K223041 | Renasys Edge (66803126)OMP · Traditional | Smith & Nephew Medical Limited | 11/22/2022SE |
| K212359 | PWD Negative Pressure Wound Therapy SystemOMP · Traditional | Applied Tissue Technologies, LLC | 09/21/2022SE |
| K214112 | Invia Ease Negative Pressure Wound Therapy (NPWT) SystemOMP · Traditional | Medela AG | 07/26/2022SE |
| K220560 | Dermatac DrapeOMP · Traditional | 3M | 07/14/2022SE |
| K220660 | Prevena Restor Adapti-Form DressingOMP · Traditional | 3M Healthcare Business Group | 07/01/2022SE |
| K210107 | Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy SystemOMP · Traditional | Genadyne Biotechnologies, Inc. | 06/01/2022SE |
| K211571 | Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitOMP · Traditional | Zhejiang Longterm Medical Technology Co., Ltd. | 05/31/2022SE |
| K202783 | Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film DressingOMP · Traditional | Smith & Nephew Medical Limited | 01/14/2022SE |
| K211318 | PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative…OMP · Traditional | Smith Nephew Medical Limited | 01/05/2022SE |
| K202898 | Tzoar 207 Negative Pressure Wound Therapy (NPWT) SystemOMP · Traditional | Lightstone Medical Products (Ningbo) Co, Ltd. | 12/30/2021SE |
| K211521 | 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large…OMP · Traditional | 3M Healthcare Business Group | 12/20/2021SE |
| K211277 | Theia NPWT Foam Wound Dressing KitOMP · Traditional | Clear Choice Therapeutics, Inc. | 12/16/2021SE |
| K202823 | Innomed NPWT Silicone Foam DressingOMP · Traditional | Zhejiang Longterm Medical Technology Co., Ltd. | 12/15/2021SE |
| K203316 | V.A.C.ULTA Negative Pressure Wound Therapy SystemOMP · Traditional | Kci, A Part of 3M Health Care Business Group | 10/27/2021SE |
| K212320 | Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small…OMP · Traditional | 3M Healthcare Business Group | 09/28/2021SE |
| K203693 | Nisus Touch Negative Pressure Wound Therapy PumpOMP · Traditional | Cork Medical Products, LLC | 08/13/2021SE |
| K203369 | Avance Solo Negative Pressure Wound Therapy (NPWT) SystemOMP · Traditional | Molnlycke Health Care Us, LLC | 07/01/2021SE |
| K202217 | Kendall NPWT Incision Management DeviceOMP · Traditional | Cardinalhealth | 06/04/2021SE |
| K202157 | PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative…OMP · Traditional | Smith & Nephew Medical Limited | 10/30/2020SE |
| K200223 | PocketDoc Micro Wound Therapy SystemOMP · Traditional | Pensar Medical, LLC | 10/23/2020SE |
| K191101 | Kendall NPWT Incision Management Dressing KitOMP · Traditional | Cardinalhealth | 07/31/2020SE |
| K201571 | ACTIV.A.C. Negative Pressure Wound Therapy SystemOMP · Special | Kci USA, Inc. | 07/08/2020SE |
| K200390 | V.A.C. DERMATAC DrapeOMP · Traditional | Kci USA, Inc. | 05/18/2020SE |
| K190028 | Uno 30OMP · Traditional | Genadyne Biotechnologies | 01/15/2020SE |
| K191760 | PICO 14 Single Use Negative Pressure Wound Therapy SystemOMP · Traditional | Smith & Nephew Medical Limited | 12/05/2019SE |
| K190697 | PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management…OMP · Traditional | Kci USA, Inc. | 11/22/2019SE |
| K190119 | Foryou NPWT Dressing KitOMP · Traditional | 4l Health Co., Ltd. | 11/01/2019SE |
| K182722 | XLR8 Abdominal Wound Dressing KitOMP · Traditional | Genadyne Biotechnologies | 09/27/2019SE |
| K191460 | PWD Platform Wound Dressing 3 x 5 OblongOMP · Special | Applied Tissue Technologies, LLC | 07/02/2019SE |
| K182458 | Longterm NPWT Foam Dressing KitOMP · Traditional | Zhejiang Longterm Medical Technology Co., Ltd. | 05/23/2019SE |
| K181505 | V.A.C. DERMATAC DrapeOMP · Traditional | Kci USA, Inc. | 03/28/2019SE |
| K181929 | MiMo(TM) Negative Pressure Wound Therapy SystemOMP · Traditional | Baymax Research, Inc. | 03/27/2019SE |
| K181822 | RENASYS Touch; RENASYS Y-ConnectorOMP · Traditional | Smith & Nephew Medical Limited | 03/21/2019SE |
| K183543 | ACTIV.A.C. Therapy UnitOMP · Traditional | Kci USA, Inc. | 03/20/2019SE |
| K181507 | PREVENA RESTOR(TM) Incision Management SystemOMP · Traditional | Kci USA, Inc. | 02/15/2019SE |
| K182191 | Invia Abdominal Dressing KitOMP · Traditional | Medela AG | 02/01/2019SE |
| K182323 | PICO 7Y Single Use Negative Pressure Wound Therapy SystemOMP · Traditional | Smith & Nephew Medical Limited | 01/18/2019SE |
| K182409 | Applied Tissue Technologies PWD Platform Wound DressingOMP · Traditional | Applied Tissue Technologies, LLC | 01/11/2019SE |
| K181204 | RENASYS Y-Connector; RENASYS TOUCHOMP · Traditional | Smith & Nephew Medical Limited | 01/10/2019SE |
| K180840 | UNO Negative Pressure Wound Therapy SystemOMP · Traditional | Genadyne Biotechnologies, Inc. | 11/30/2018SE |
| K180415 | Invia White Foam NPWTOMP · Traditional | Medela AG | 11/02/2018SE |
| K180205 | AVELLE Negative Pressure Wound Therapy SystemOMP · Traditional | Convatec Limited | 10/19/2018SE |
| K180698 | PICO 7 Single Use Negative Pressure Wound Therapy SystemOMP · Traditional | Smith & Nephew Medical Limited | 08/21/2018SE |
| K173407 | VT - 100, VT - 200OMP · Traditional | Carilex Medical, Inc. | 08/09/2018SE |
| K172725 | VT Dressing KitsOMP · Traditional | Carilex Medical, Inc. | 06/08/2018SE |
| K180855 | Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemOMP · Traditional | Kci USA, Inc. | 06/01/2018SE |
| K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…OMP · Traditional | Medela AG | 05/09/2018SE |
| K180618 | PICO Single Use Negative Pressure Wound Therapy SystemOMP · Special | Smith & Nephew Medical Limited | 04/20/2018SE |
| K180614 | PICO Single Use Negative Pressure Wound Therapy SystemOMP · Special | Smith & Nephew Medical Limited | 04/06/2018SE |
| K173426 | PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemOMP · Traditional | Kci USA, Inc. | 03/09/2018SE |
| K173447 | V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative…OMP · Traditional | Kci USA, Inc. | 03/02/2018SE |
| K172005 | PICO 7 Single Use Negative Pressure Wound Therapy SystemOMP · Traditional | Smith & Nephew Medical Limited | 02/02/2018SE |
| K171499 | Occlusion Detection Dressing KitOMP · Traditional | Cardinalhealth | 09/22/2017SE |
| K172521 | PICO Single Use Negative Pressure Wound Therapy SystemOMP · Special | Smith & Nephew Medical Limited | 09/20/2017SE |
| K172519 | PICO Single Use Negative Pressure Wound Therapy SystemOMP · Special | Smith & Nephew Medical Limited | 09/15/2017SE |
| K162610 | NEXA Negative Pressure Wound Therapy SystemOMP · Traditional | Nexa Medical , Ltd. | 06/08/2017SE |
| K162159 | VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingOMP · Traditional | Vr Medical Technologies, LLC | 04/28/2017SE |
| K163387 | PICO Single Use Negative Pressure Wound Therapy SystemOMP · Traditional | Smith & Nephew Medical Limited | 04/18/2017SE |
| K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…OMP · Traditional | Medela AG | 04/06/2017SE |
| K161599 | UNO Negative Pressure Wound Therapy SystemOMP · Traditional | Genadyne Biotechnologies, Inc. | 04/06/2017SE |
| K161432 | MyNeWT Negative Pressure Wound Therapy SystemOMP · Traditional | Stortford Medical, LLC | 02/08/2017SE |
| K162790 | V.A.C.ULTA Negative Pressure Wound Therapy SystemOMP · Traditional | Kci USA, Inc. (Kinetic Concepts, Inc.) | 01/26/2017SE |
| K161418 | Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery SetOMP · Traditional | Cardinalhealth | 01/19/2017SE |
| K160487 | V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemOMP · Traditional | Kci USA, Inc. | 12/09/2016SE |
| K161128 | Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days…OMP · Traditional | Medela AG | 12/01/2016SE |
| K150960 | WoundPro Negative Pressure Wound Therapy SystemOMP · Traditional | Pensar Medical, LLC | 12/01/2016SE |
| K161935 | Avance Foam Dressing Kit - XLOMP · Traditional | Molnlycke Health Care Us, LLC | 11/04/2016SE |
| K161948 | Avance Gauze Dressing KitsOMP · Traditional | Molnlycke Health Care Us, LLC | 11/03/2016SE |
| K161797 | Avance Tubing, Avance Y-Connector, Avance ViewPadOMP · Traditional | Molnlycke Health Care Us, LLC | 10/19/2016SE |
| K161410 | VT·One, VT·One 60daysOMP · Traditional | Carilex Medical, Inc. | 10/13/2016SE |
| K161897 | PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsOMP · Traditional | Kci USA, Inc. (Kinetic Concepts, Inc.) | 10/04/2016SE |
| K152163 | Renasys GoOMP · Traditional | Smith & Nephew, Inc. | 09/29/2016SE |
| K162129 | RENASYS-G Gauze Dressing Kits with Soft PortOMP · Special | Smith & Nephew, Inc. | 08/31/2016SE |
| K161570 | Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium…OMP · Traditional | Lc Medical Concepts, Inc. | 08/29/2016SE |
| K153209 | RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH…OMP · Traditional | Smith & Nephew Medical, Ltd. | 08/04/2016SE |
| K160451 | V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...OMP · Traditional | Kci USA, Inc. (Kinetic Concepts, Inc.) | 06/20/2016SE |
| K153199 | Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus…OMP · Traditional | Kci USA, Inc. | 02/29/2016SE |
| K151263 | Venturi Gauze Wound Care Sets with Portal DrainOMP · Traditional | Talley Group, Ltd. | 02/19/2016SE |
| K151436 | PICO Single Use Negative Pressure Wound Therapy SystemOMP · Traditional | Smith & Nephew Medical, Ltd. | 01/28/2016SE |
| K152741 | Mepiseal Soft Silicone SealantOMP · Traditional | Molnlycke Health Care Us, LLC | 01/22/2016SE |
| K150459 | FloSure Ventilation PatchOMP · Traditional | Simex Medizintechnik GmbH | 01/05/2016SE |
| K143004 | VENTURI MiNO TG600/14OMP · Traditional | Talley Group, Ltd. | 01/05/2016SE |
| K150006 | Prevena Incision Management System with Peel & Place Dressing, Prevena Incision…OMP · Traditional | Kci USA, Inc. | 11/06/2015SE |
| K151872 | Avance Y-Connector SOMP · Traditional | Molnlycke Health Care Us, LLC | 11/02/2015SE |
| K151261 | Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit…OMP · Traditional | Medela AG | 10/07/2015SE |
| K150124 | Cardinal Health NPWT PRO HCOMP · Traditional | Cardinalhealth | 09/02/2015SE |
| K141017 | Prevena Incision Management System with Peel & Dressing, Prevena Incision Management…OMP · Traditional | Kci USA, Inc. (Kinetic Concepts, Inc.) | 08/20/2015SE |
| K143133 | RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…OMP · Traditional | Smith & Nephew, Inc. | 07/23/2015SE |
| K151326 | RENASYS¿ EZ PLUS Negative Pressure Wound Therapy DeviceOMP · Special | Smith & Nephew, Inc. | 07/16/2015SE |
| K143726 | XLR8 Plus (XLR8+)OMP · Traditional | Genadyne Biotechnologies, Inc. | 06/19/2015SE |
| K142626 | Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set…OMP · Traditional | Medela AG | 06/12/2015SE |
| K151240 | extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure…OMP · Special | Devon Medical Products | 06/09/2015SE |
| K142385 | Whisper Pump SystemOMP · Traditional | Wound RX Medical, LLC | 05/22/2015SE |
| K142646 | XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit andOMP · Traditional | Genadyne Biotechnologies, Inc. | 04/30/2015SE |
| K142979 | RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft…OMP · Traditional | Smith & Nephew, Inc. | 04/29/2015SE |
| K143016 | Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at HomeOMP · Traditional | Cardinalhealth | 04/20/2015SE |
| K141961 | Genadyne Spiro Foam Dressing KitOMP · Traditional | Genadyne Biotechnologies, Inc. | 03/26/2015SE |
| K141847 | Avance Foam Dressing KitsOMP · Traditional | Molnlycke Health Care Us, LLC | 03/26/2015SE |
| K142916 | SVED Wound Treatment SystemOMP · Traditional | Cardinalhealth | 03/04/2015SE |
| K143301 | NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA KitOMP · Traditional | Integrated Healing Technologies | 03/03/2015SE |
| K142956 | NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome KitOMP · Traditional | Integrated Healing Technologies | 02/24/2015SE |
| K143362 | extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canisterOMP · Special | Devon Medical Products | 02/03/2015SE |
| K133333 | Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing KitOMP · Traditional | Blue Ocean Medical Product, LLC | 12/31/2014SE |
| K141926 | Invia Endure Negative Pressure Wound Therapy SystemOMP · Traditional | Medela AG | 12/19/2014SE |
| K140022 | Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus NPWT…OMP · Traditional | Cork Medical Products, LLC | 10/24/2014SE |
| K141437 | XLR8 Plus (XLR8+)OMP · Special | Genadyne Biotechnologies, Inc. | 09/19/2014SE |
| K140634 | extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…OMP · Traditional | Devon Medical, Inc. | 09/19/2014SE |
| K141033 | Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG…OMP · Traditional | Argentum Medical, LLC | 09/12/2014SE |
| K132225 | ExtricareOMP · Traditional | Devon Medical, Inc. | 05/15/2014SE |
| K132004 | NPWT Wound Dressing Kit- Medium, NPWT Wound Dressing Kit- LargeOMP · Traditional | Creo Quality, LLC | 05/02/2014SE |
| K133232 | Prevena Incision Management System with Customizable Dressing, Prevena Incision…OMP · Traditional | Kci USA, Inc. (Kinetic Concepts, Inc.) | 03/24/2014SE |
| K132936 | Novopore DressingOMP · Traditional | Polynovo Biomaterials Pty, Ltd. | 03/04/2014SE |
| K133276 | V.A.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing, Granufoam…OMP · Special | Kci USA, Inc. | 11/19/2013SE |
| K132741 | V.A.C. Via Negative Pressure Wound Therapy SystemOMP · Special | Kci USA, Inc. | 11/15/2013SE |
| K122490 | KulavacOMP · Traditional | CG Bio Co., Ltd. | 11/13/2013SE |
| K132446 | Renasys Ez Max Negative Pressure Wound Therapy DeviceOMP · Special | Smith & Nephew, Inc. | 10/23/2013SE |
| K132252 | Extricare 100CC/ 250CC/ 400CC CanistersOMP · Special | Devon Medical | 09/27/2013SE |
| K121817 | Vcare aOMP · Traditional | IVT Medical, Ltd. | 09/17/2013SE |
| K131464 | Extricare NPWT Foot DressingOMP · Special | Devon Medical, Inc. | 08/13/2013SE |
| K123507 | Kci NPWT Gauze DressingOMP · Traditional | Kci USA, Inc. | 04/04/2013SE |
| K113236 | Foryou NPWT DeviceOMP · Traditional | Foryou Medical Electronics Co, Ltd. | 02/12/2013SE |
| K122132 | Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large)…OMP · Traditional | Molnlycke Health Care | 01/17/2013SE |
| K123878 | Prevena Incision Management System with Customizable DressingOMP · Special | Kci USA, Inc. (Kinetic Concepts, Inc.) | 01/15/2013SE |
| K112853 | Voltera Powered Suction PumpOMP · Traditional | Suzric Enterprise Co., Ltd. | 11/09/2012SE |
| K121883 | Prevena Incision Management System with Customizable Dressing, Prevena Customizable…OMP · Traditional | Kci USA, Inc. (Kinetic Concepts, Inc.) | 10/11/2012SE |
| K120499 | Abthera Open Abdomen Negative Pressure Therapy SystemOMP · Traditional | Kci USA, Inc. (Kinetic Concepts, Inc.) | 10/05/2012SE |
| K113678 | Invia Motion Negative Pressure Wound Therapy SystemOMP · Traditional | Medela AG | 10/01/2012SE |
| K113291 | Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: SIM-EX200 and…OMP · Traditional | Simex Medizintechnik GmbH | 08/30/2012SE |
| K113199 | Kevo NPWT-AHEMO30 and a HEMO45 Foam Dressing KitOMP · Traditional | Kevo Medical Supplies | 07/30/2012SE |
| K111949 | Ac Wound Treatment SystemOMP · Traditional | Nanovibronix, Inc. | 06/29/2012SE |
| K120033 | Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom…OMP · Traditional | Kci USA, Inc. | 05/31/2012SE |
| K112127 | Pico Single Use Negative Pressure Wound Therapy SystemOMP · Traditional | Smith & Nephew, Inc. | 05/16/2012SE |
| K110078 | ExtricareOMP · Traditional | Devon Medical Products, Inc. | 02/10/2012SE |
| K112458 | Prospera Pro-I, Pro-Ii and Pro-Iii Negative Pressure Wound Therapy SystemOMP · Special | Medica-Rents Co., Ltd. | 01/05/2012SE |
| K111170 | PicoOMP · Traditional | Smith & Nephew, Inc. | 12/15/2011SE |
| K111333 | Antlia III Wound Treatment SystemOMP · Special | Innovative Therapies, Inc. | 08/08/2011SE |
| K111280 | V.A.C. 125 Negative Pressure Wound Therapy UnitOMP · Traditional | Kci USA, Inc. | 07/21/2011SE |
| K110647 | Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound…OMP · Traditional | Smith & Nephew, Inc. | 06/22/2011SE |
| K103156 | V.A.C. Veraflo Cleanse Dressing SystemOMP · Special | Kci USA, Inc. (Kinetic Concepts, Inc.) | 03/14/2011SE |
| K100823 | Wound Pro ApexOMP · Traditional | Accuro Medical Products, LLC | 01/24/2011SE |
| K102956 | V.A.C. Granufoam Silver Small Dressing; V.A.C. Granufoam Silver Medium Dressing; V.A.C.…OMP · Special | Kci USA, Inc. (Kinetic Concepts, Inc.) | 12/15/2010SE |
| K100657 | V.A.C. Ulta Negative Pressure Wound Therapy System (V.A.C. Ulta Therapy System) Model…OMP · Traditional | Kci USA, Inc. (Kinetic Concepts, Inc.) | 09/17/2010SE |
| K102001 | Modification to Renasys Ez Plus Negative Pressure Wound TherapyOMP · Special | Smith & Nephew, Inc. | 08/06/2010SE |
| K092992 | A4-XLR8 Foam DressingOMP · Traditional | Genadyne Biotechnologies, Inc. | 06/29/2010SE |
| K100821 | Prevena Incision Management SystemOMP · Traditional | Kci USA, Inc. | 06/11/2010SE |
| K093526 | V.A.C. Via Therapy System, V.A.C. Via Negative Pressure Therapy Unit, V.A.C. Via…OMP · Traditional | Kci USA, Inc. (Kinetic Concepts, Inc.) | 03/10/2010SE |
| K091585 | Vac Therapy System, Models 340000, M8259999, 320000, M8259968 and 320100OMP · Traditional | Kci USA, Inc. | 12/29/2009SE |
| K093564 | Sved Wound Treatment SystemOMP · Special | Innovative Therapies, Inc. | 11/25/2009SE |
| K090258 | Venturi NPWT V. II Advanced Vacuum SystemOMP · Traditional | Talley Medical | 08/25/2009SE |
| K091470 | Ranasys Ez Negative Pressure Wound Therapy System, Model 66800059OMP · Traditional | Smith & Nephew, Inc. | 07/09/2009SE |
| K090638 | Genadyne A4-XLR8 Wound Vacuum SystemOMP · Special | Genadyne Biotechnologies, Inc. | 04/29/2009SE |
| K090130 | Atmos S041 WoundOMP · Traditional | Atmos, Inc. | 04/02/2009SE |
| K083357 | Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510OMP · Traditional | Kci USA, Inc. | 03/04/2009SE |
| K083375 | Renasys Go Negative Pressure Wound TherapyOMP · Traditional | Smith & Nephew, Inc. | 02/25/2009SE |
| K082676 | Genadyne A4 Wound Vacuum SystemOMP · Traditional | Genadyne Biotechnologies, Inc. | 12/18/2008SE |
| K082415 | Prodigy NPWT System Model Prodigy 800VOMP · Traditional | Premco Medical Systems, Inc. | 11/25/2008SE |
| K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsOMP · Traditional | Smith & Nephew, Inc. | 11/14/2008SE |
| K080275 | NPD 1000 Negative Pressure Wound Therapy SystemOMP · Traditional | Iasis Medical, Inc. | 10/09/2008SE |
| K082311 | Exsudex Wound Drainage PumpOMP · Abbreviated | The Medical Company | 10/08/2008SE |
| K082426 | Renasys EzOMP · Special | Smith & Nephew, Inc. | 09/05/2008SE |
| K080357 | Medela Invia Wound TherapyOMP · Traditional | Medela AG | 07/24/2008SE |
| K080897 | Venturi Negative Pressure Wound Therapy SystemOMP · Traditional | Talley Medical | 07/15/2008SE |
| K063740 | V.A.C. Therapy Systems - Info V.A.C. Therapy Uniy, Model M6257766OMP · Traditional | Kci USA, Inc. | 06/07/2007SE |
| K063692 | V.A.C. Therapy Systems-Acti V.A.C. Therapy Unit Model# 340000OMP · Traditional | Kci USA, Inc. | 06/07/2007SE |
| K071301 | Antlia I Wound Irrigation SystemOMP · Traditional | Innovative Therapies, Inc. | 05/24/2007SE |
| K070904 | Antlia II Suction Pump SystemOMP · Traditional | Innovative Therapies, Inc. | 04/13/2007SE |
| K061919 | Versatile 1 Ezcare Wound Vacuum SystemOMP · Traditional | Blue Sky Medical Group Incorporated | 02/05/2007SE |
| K063590 | V.A.C. Freedom Canister, Model M6275421; V.A.C. Ats Canister, Models K6275422, M6275423OMP · Special | Kci USA, Inc. | 01/25/2007SE |
| K063426 | V.A.C. Ats Large (1000 ML) Canister with Gel, Models M6275093/5, M6275093/10OMP · Special | Kci USA, Inc. | 12/13/2006SE |
| K062456 | Novaspine Powered Suction Pump PRO-1OMP · Traditional | Novaspine, LLC | 10/16/2006SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1176-2025 Class II | 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7…Due to increase in complaints related to leak alarms | Kci USA, Inc. | 01/17/2025Open, Classified |
| Z-0507-2025 Class II | V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative…Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion… | Kci USA, Inc. | 11/05/2024Open, Classified |
| Z-0516-2025 Class II | RENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit from a…Due to issues with battery depletion and inability to recharge if the batteries are not appropriately… | Smith & Nephew Medical, Ltd. | 10/02/2024Open, Classified |
| Z-1597-2024 Class II | RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit…Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and… | Smith & Nephew Medical, Ltd. | 03/11/2024Open, Classified |
| Z-1596-2024 Class II | RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit…Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and… | Smith & Nephew Medical, Ltd. | 03/11/2024Open, Classified |
| Z-2542-2020 Class II | ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI…The device may power off without notification to the user resulting in a stoppage of negative pressure wound… | Kci USA, Inc. | 06/08/2020Terminated |
| Z-2544-2020 Class II | Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product…Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the… | Cardinal Health 200, LLC | 06/04/2020Terminated |
| Z-2543-2020 Class II | Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The…Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the… | Cardinal Health 200, LLC | 06/04/2020Terminated |
| Z-0773-2020 Class II | Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam…Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging. | Medela Inc | 12/02/2019Terminated |
| Z-2528-2018 Class II | Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative…Device may display a battery missing error. | Medela Inc | 02/07/2018Terminated |
| Z-2171-2017 Class II | 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number…Potential sterile barrier breach | Kci USA, Inc. | 04/28/2017Terminated |
| Z-1042-2017 Class II | Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit…Lack of 510k clearance for design modification. | Smith & Nephew, Inc. | 11/11/2016Open, Classified |
| Z-1041-2017 Class II | Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for…Lack of 510k clearance for design modification. | Smith & Nephew, Inc. | 11/11/2016Open, Classified |
| Z-2848-2016 Class II | RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the…Sterility seal integrity failures on the Renasys Sterile Transparent Film | Smith & Nephew, Inc. | 07/21/2016Open, Classified |
| Z-0600-2016 Class II | ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application…There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile… | Kci USA, Inc. | 11/25/2015Terminated |
| Z-0070-2015 Class II | V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help…A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with… | KCI USA, Inc. | 09/18/2014Terminated |
| Z-2688-2014 Class II | RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who…Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification. | Smith & Nephew, Inc. | 08/13/2014Terminated |
| Z-0041-2015 Class II | RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage:…RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. | Smith & Nephew, Inc. | 07/18/2014Terminated |
| Z-0040-2015 Class II | RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ…RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. | Smith & Nephew, Inc. | 07/18/2014Terminated |
| Z-0039-2015 Class II | RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ…RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. | Smith & Nephew, Inc. | 07/18/2014Terminated |
| Z-1142-2014 Class II | PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena…Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult… | Kci USA, Inc. | 01/30/2014Terminated |
| Z-1141-2014 Class II | PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage:…Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult… | Kci USA, Inc. | 01/30/2014Terminated |
| Z-1140-2014 Class II | PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision…Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult… | Kci USA, Inc. | 01/30/2014Terminated |
| Z-1139-2014 Class II | PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena…Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult… | Kci USA, Inc. | 01/30/2014Terminated |
| Z-1138-2014 Class II | PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision…Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult… | Kci USA, Inc. | 01/30/2014Terminated |
| Z-1137-2014 Class II | PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System…Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult… | Kci USA, Inc. | 01/30/2014Terminated |
| Z-1136-2014 Class II | PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena…Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult… | Kci USA, Inc. | 01/30/2014Terminated |
| Z-1135-2014 Class II | PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision…Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult… | Kci USA, Inc. | 01/30/2014Terminated |
| Z-1162-2014 Class II | Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The…Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump… | Smith & Nephew Inc. | 01/09/2014Terminated |
| Z-1161-2014 Class II | Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961…Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump… | Smith & Nephew Inc. | 01/09/2014Terminated |
| Z-1160-2014 Class II | Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935…Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump… | Smith & Nephew Inc. | 01/09/2014Terminated |
| Z-1159-2014 Class II | Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port…Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump… | Smith & Nephew Inc. | 01/09/2014Terminated |
| Z-1158-2014 Class II | Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795…Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump… | Smith & Nephew Inc. | 01/09/2014Terminated |
| Z-1157-2014 Class II | Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are…Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump… | Smith & Nephew Inc. | 01/09/2014Terminated |
| Z-1068-2014 Class II | Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy…Modification of the bacterial overflow guard (filter) and related changes to product labeling. | Smith & Nephew Inc. | 11/14/2013Terminated |
| Z-1067-2014 Class II | Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy SystemModification of the bacterial overflow guard (filter) and related changes to product labeling. | Smith & Nephew Inc. | 11/14/2013Terminated |
| Z-0009-2013 Class II | Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical…Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without… | Accuro Medical Product LLC | 08/31/2012Terminated |
| Z-0875-2012 | ***REF 66800694***Qty 10***smith&nephew***RENASYS Port Foam Dressing Kit…On 12/14/2010, Smith & Nephew, Inc. Wound Management Division in St. Petersburg, FL recalled their RENASYS… | Smith & Nephew Inc. | 12/14/2010Terminated |
| Z-2609-2010 | Engenex Non Acute Care Suction Pump for use with Engenex Negative Pressure Wound TherapyReduced vacuum capacity has been reported with a small number of units caused by electrostatic discharge… | Convatec Inc. | 07/09/2010Terminated |
| Z-0310-2011 | smith&nephew EZCARE Negative Pressure Rx only. 100-240 V 12 V 50/60 Hz 90VA T1A 250 V…Smith&Nephew Inc., Advance Wound Management, St Petersburg, FL is recalling their Ezcare Negative Pressure… | Smith & Nephew Inc. | 01/29/2010Terminated |
| Z-0667-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield…Power cords may crack and fail inside plug with potential for fire hazard. | KCI USA, Inc. | 11/04/2009Terminated |
| Z-0666-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield…Power cords may crack and fail inside plug with potential for fire hazard. | KCI USA, Inc. | 11/04/2009Terminated |
| Z-0665-2010 | AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield…Power cords may crack and fail inside plug with potential for fire hazard. | KCI USA, Inc. | 11/04/2009Terminated |
| Z-2045-2009 | Engenex Bio-Dome Easy Release Dressing Kit, XL; Product Code 446553; Advanced Negative…Labeling: The expiration date does not appear on the product label. | ConvaTec | 07/29/2009Terminated |
| Z-2044-2009 | Engenex Cover Strip; Product Code 446471; Advanced Negative Wound Therapy System…Labeling: The expiration date does not appear on the product label. | ConvaTec | 07/29/2009Terminated |
| Z-2043-2009 | Engenex Wound Cover; Product Code 446470; Advanced Negative Pressure Wound Therapy…Labeling: The expiration date does not appear on the product label. | ConvaTec | 07/29/2009Terminated |
| Z-1814-2009 | ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy…Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched. | ConvaTec | 07/13/2009Terminated |