510(k) Report

Devices descending from K945062

219 later devices reach Vacplus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042134Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated20041592
+1K021500Vacuum Assisted ClosureKinetic Concepts, Inc.20020—
+1K992448V.a.C. PlusKinetic Concepts, Inc.2000150—
+1K971548AmbuvacKinetic Concepts, Inc.1997156—
+2K113291Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and…Simex Medizintechnik GmbH20124—
+2K110647Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound…Smith & Nephew, Inc.2011486
+2K082311Exsudex Wound Drainage PumpThe Medical Company20080—
+2K080897Venturi Negative Pressure Wound Therapy SystemTalley Medical20084—
+2K061919Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated20071071
+2K062456Novaspine Powered Suction Pump Pro-1Novaspine, LLC200616—
+2K061367Bluesky Vista Wound Vacuum System, Model 100.0500Blue Sky Medical Group Incorporated200624—
+2K061788Boehringer Laboratories Suction Pump SystemBoehringer Laboratories200655
+2K061435Medela Vario Suction PumpsMedela AG2006120—
+2K052456Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated2005127—
+2K050129Celleration Mist Therapy System 5.1Celleration, Inc.20056—
+2K032310Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc.20031122
+2K022011V.a.C. Abdominal DressingKinetic Concepts, Inc.2003171
+2K021501V.a.C. Instillamat (Vacuum Assisted Closure InstillamatKinetic Concepts, Inc.200230—
+3K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitZhejiang Longterm Medical Technology Co., Ltd.20220—
+3K182458Longterm NPWT Foam Dressing KitZhejiang Longterm Medical Technology Co., Ltd.20190—
+3K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC20160—
+3K153663Vario 8/18/ciMedela AG20161—
+3K151263Venturi Gauze Wound Care Sets with Portal DrainTalley Group, Ltd.20161—
+3K143004VENTURI MiNO TG600/14Talley Group, Ltd.20160—
+3K142979RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft…Smith & Nephew, Inc.2015121
+3K143301NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA KitIntegrated Healing Technologies20150—
+3K142956NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome KitIntegrated Healing Technologies20150—
+3K141255Simex Subglottic Aspiration SystemSimex Medizintechnik GmbH20143—
+3K132225ExtricareDevon Medical, Inc.20148—
+3K132936Novopore DressingPolynovo Biomaterials Pty, Ltd.20140—
+3K122490KulavacCG Bio Co., Ltd.20130—
+3K123507Kci NPWT Gauze DressingKci USA, Inc.201311—
+3K122132Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large)…Molnlycke Health Care201321—
+3K112853Voltera Powered Suction PumpSuzric Enterprise Co., Ltd.20123—
+3K110078ExtricareDevon Medical Products, Inc.20129—
+3K112458Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy SystemMedica-Rents Co., Ltd.201215—
+3K112784Renasys AB Abominal Dressing KitSmith & Nephew, Inc.201110—
+3K100823Wound Pro ApexAccuro Medical Products, LLC2011101
+3K100657V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy System) Model…Kci USA, Inc. (Kinetic Concepts, Inc.)201019—
+3K100787Renasys F/-AB Abdominal Wound Dressing KitSmith & Nephew, Inc.201011—
+3K093261MOVESThornhill Research, Inc.20107Class I
+3K090258Venturi NPWT V. II Advanced Vacuum SystemTalley Medical20091—
+3K091038AS 1000 Ultrasound Wound Therapy SystemArobella Medical, LLC20090—
+3K090489Abthera Open Abdomen Dressing, Model: M8275026Kci USA, Inc.20091—
+3K090130Atmos S041 WoundAtmos, Inc.20091—
+3K083357Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510Kci USA, Inc.20091—
+3K082676Genadyne A4 Wound Vacuum SystemGenadyne Biotechnologies, Inc.200811—
+3K082211Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc.2008681
+3K082426Renasys EZSmith & Nephew, Inc.2008584
+3K080357Medela Invia Wound TherapyMedela AG2008751
+3K063692V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000Kci USA, Inc.2007601
+3K063740V.a.C. Therapy Systems - Info V.a.C. Therapy Uniy, Model M6257766Kci USA, Inc.200714
+3K071301Antlia I Wound Irrigation SystemInnovative Therapies, Inc.20073—
+3K070904Antlia II Suction Pump SystemInnovative Therapies, Inc.2007109—
+3K063590V.a.C. Freedom Canister, Model M6275421; V.a.C. Ats Canister, Models K6275422, M6275423Kci USA, Inc.20070—
+3K062544AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC200751
+3K063426V.a.C. Ats Large (1000 ML) Canister with Gel, Models M6275093/5, M6275093/10Kci USA, Inc.20062—
+3K062227V.a.C. Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)200632
+3K060046DermastreamEnzysurge, Ltd.20061—
+3K050261V.a.C. Granufoam Silver Protection DressingKinetic Concepts, Inc.20057—
+3K041642V.a.C. Granufoam Silver DressingKinetic Concepts, Inc.20058—
+4K243576RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze…Smith & Nephew Medical, Ltd.20251—
+4K241023Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc.20240—
+4K221223extriCARE® 3000 Negative Wound Pressure Therapy SystemAlleva Medical Devices20230—
+4K221676ExsaltaDrw Medical20220—
+4K202783Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film DressingSmith & Nephew Medical Limited20220—
+4K202898Tzoar 207 Negative Pressure Wound Therapy (NPWT) SystemLightstone Medical Products (Ningbo) Co, Ltd.20210—
+4K183543ACTIV.A.C. Therapy UnitKci USA, Inc.201941
+4K173407VT - 100, VT - 200Carilex Medical, Inc.20181—
+4K172725VT Dressing KitsCarilex Medical, Inc.20181—
+4K162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC20173—
+4K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Medela AG201781
+4K162790V.A.C.ULTA Negative Pressure Wound Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)201731
+4K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc.20160—
+4K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC20160—
+4K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC20160—
+4K161410VT·One, VT·One 60daysCarilex Medical, Inc.20160—
+4K162129RENASYS-G Gauze Dressing Kits with Soft PortSmith & Nephew, Inc.20160—
+4K153209RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH…Smith & Nephew Medical, Ltd.20165—
+4K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd.20162—
+4K141017Prevena Incision Management System with Peel & Dressing, Prevena Incision Management…Kci USA, Inc. (Kinetic Concepts, Inc.)201510—
+4K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…Smith & Nephew, Inc.20155—
+4K151326RENASYS¿ EZ PLUS Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.20150—
+4K142626Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set…Medela AG201512—
+4K142385Whisper Pump SystemWound RX Medical, LLC20150—
+4K141847Avance Foam Dressing KitsMolnlycke Health Care Us, LLC201514—
+4K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+4K141926Invia Endure Negative Pressure Wound Therapy SystemMedela AG20145—
+4K140022Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus NPWT…Cork Medical Products, LLC20145—
+4K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…Devon Medical, Inc.20144—
+4K141033Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG…Argentum Medical, LLC20140—
+4K140049Moves SLCThornhill Research, Inc.20141—
+4K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC20140—
+4K132004NPWT Wound Dressing Kit- Medium, NPWT Wound Dressing Kit- LargeCreo Quality, LLC20141—
+4K130852Avance® Foam Abdominal Dressing KitMolnlycke Health Care20143—
+4K121817Vcare aIVT Medical, Ltd.20130—
+4K113236Foryou NPWT DeviceForyou Medical Electronics Co, Ltd.20130—
+4K120499Abthera Open Abdomen Negative Pressure Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)20120—
+4K113678Invia Motion Negative Pressure Wound Therapy SystemMedela AG201211—
+4K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc.20112—