510(k) Report

Devices descending from K042134

159 later devices reach Versatile 1 Wound Vacuum System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113291Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and…Simex Medizintechnik GmbH20124—
+1K110647Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound…Smith & Nephew, Inc.2011486
+1K080897Venturi Negative Pressure Wound Therapy SystemTalley Medical20084—
+1K061919Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated20071071
+1K062456Novaspine Powered Suction Pump Pro-1Novaspine, LLC200616—
+1K061367Bluesky Vista Wound Vacuum System, Model 100.0500Blue Sky Medical Group Incorporated200624—
+1K061788Boehringer Laboratories Suction Pump SystemBoehringer Laboratories200655
+1K061435Medela Vario Suction PumpsMedela AG2006120—
+1K052456Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated2005127—
+1K050129Celleration Mist Therapy System 5.1Celleration, Inc.20056—
+2K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC20160—
+2K153663Vario 8/18/ciMedela AG20161—
+2K151263Venturi Gauze Wound Care Sets with Portal DrainTalley Group, Ltd.20161—
+2K143004VENTURI MiNO TG600/14Talley Group, Ltd.20160—
+2K142979RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft…Smith & Nephew, Inc.2015121
+2K143301NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA KitIntegrated Healing Technologies20150—
+2K142956NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome KitIntegrated Healing Technologies20150—
+2K141255Simex Subglottic Aspiration SystemSimex Medizintechnik GmbH20143—
+2K123507Kci NPWT Gauze DressingKci USA, Inc.201311—
+2K122132Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large)…Molnlycke Health Care201321—
+2K112853Voltera Powered Suction PumpSuzric Enterprise Co., Ltd.20123—
+2K110078ExtricareDevon Medical Products, Inc.20129—
+2K112458Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy SystemMedica-Rents Co., Ltd.201215—
+2K112784Renasys AB Abominal Dressing KitSmith & Nephew, Inc.201110—
+2K100823Wound Pro ApexAccuro Medical Products, LLC2011101
+2K093261MOVESThornhill Research, Inc.20107Class I
+2K090258Venturi NPWT V. II Advanced Vacuum SystemTalley Medical20091—
+2K091038AS 1000 Ultrasound Wound Therapy SystemArobella Medical, LLC20090—
+2K090130Atmos S041 WoundAtmos, Inc.20091—
+2K082676Genadyne A4 Wound Vacuum SystemGenadyne Biotechnologies, Inc.200811—
+2K082211Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc.2008681
+2K082311Exsudex Wound Drainage PumpThe Medical Company20080—
+2K082426Renasys EZSmith & Nephew, Inc.2008584
+2K070904Antlia II Suction Pump SystemInnovative Therapies, Inc.2007109—
+2K062544AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC200751
+3K243576RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze…Smith & Nephew Medical, Ltd.20251—
+3K221676ExsaltaDrw Medical20220—
+3K202783Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film DressingSmith & Nephew Medical Limited20220—
+3K173407VT - 100, VT - 200Carilex Medical, Inc.20181—
+3K172725VT Dressing KitsCarilex Medical, Inc.20181—
+3K162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC20173—
+3K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Medela AG201781
+3K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC20160—
+3K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC20160—
+3K161410VT·One, VT·One 60daysCarilex Medical, Inc.20160—
+3K162129RENASYS-G Gauze Dressing Kits with Soft PortSmith & Nephew, Inc.20160—
+3K153209RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH…Smith & Nephew Medical, Ltd.20165—
+3K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd.20162—
+3K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…Smith & Nephew, Inc.20155—
+3K151326RENASYS¿ EZ PLUS Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.20150—
+3K142385Whisper Pump SystemWound RX Medical, LLC20150—
+3K141847Avance Foam Dressing KitsMolnlycke Health Care Us, LLC201514—
+3K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+3K140022Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus NPWT…Cork Medical Products, LLC20145—
+3K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…Devon Medical, Inc.20144—
+3K140049Moves SLCThornhill Research, Inc.20141—
+3K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC20140—
+3K132225ExtricareDevon Medical, Inc.20148—
+3K132004NPWT Wound Dressing Kit- Medium, NPWT Wound Dressing Kit- LargeCreo Quality, LLC20141—
+3K130852Avance® Foam Abdominal Dressing KitMolnlycke Health Care20143—
+3K122490KulavacCG Bio Co., Ltd.20130—
+3K113236Foryou NPWT DeviceForyou Medical Electronics Co, Ltd.20130—
+3K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc.20112—
+3K111333Antlia Iii Wound Treatment SystemInnovative Therapies, Inc.20115—
+3K092992A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc.201031—
+3K091470Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc.2009151
+3K090638Genadyne A4-XLR8 Wound Vacuum SystemGenadyne Biotechnologies, Inc.20092—
+3K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc.2009562
+3K072904Sonoca 180/195 Wound Care SystemSoering GmbH20081—
+4K251826RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologySmith & Nephew Medical, Ltd.20250—
+4K243187Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)Cork Medical20251—
+4K241023Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc.20240—
+4K231646Carilex VT¿200-i NXCarilex Medical, Inc.20240—
+4K230677Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)Cork Medical20231—
+4K221223extriCARE® 3000 Negative Wound Pressure Therapy SystemAlleva Medical Devices20230—
+4K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitZhejiang Longterm Medical Technology Co., Ltd.20220—
+4K202898Tzoar 207 Negative Pressure Wound Therapy (NPWT) SystemLightstone Medical Products (Ningbo) Co, Ltd.20210—
+4K202823Innomed NPWT Silicone Foam DressingZhejiang Longterm Medical Technology Co., Ltd.20210—
+4K203693Nisus Touch Negative Pressure Wound Therapy PumpCork Medical Products, LLC20210—
+4K190119Foryou NPWT Dressing Kit4l Health Co., Ltd.20190—
+4K182458Longterm NPWT Foam Dressing KitZhejiang Longterm Medical Technology Co., Ltd.20190—
+4K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited20193—
+4K182191Invia Abdominal Dressing KitMedela AG20190—
+4K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC20192—
+4K181204RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited20190—
+4K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+4K180415Invia White Foam NPWTMedela AG20180—
+4K180991AG 100sHospitech Respiration, Ltd.20181—
+4K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG20183—
+4K161420Moves SLCThornhill Research, Inc.20170—
+4K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+4K161939Avance Abdominal Dressing KitMolnlycke Health Care Us, LLC20161—
+4K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC20160—
+4K152163Renasys GOSmith & Nephew, Inc.20160—
+4K152741Mepiseal Soft Silicone SealantMolnlycke Health Care Us, LLC20160—
+4K151872Avance Y-Connector SMolnlycke Health Care Us, LLC20152—
+4K143726XLR8 Plus (XLR8+)Genadyne Biotechnologies, Inc.20150—
+4K142646XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit andGenadyne Biotechnologies, Inc.20151—
+4K143016Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at HomeCardinalhealth201542
+4K141961Genadyne Spiro Foam Dressing KitGenadyne Biotechnologies, Inc.20150—