510(k) Report

Devices descending from K032310

112 later devices reach Mini V.a.C., V.a.C. Freedom, V.a.C. Ats through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitZhejiang Longterm Medical Technology Co., Ltd.20220—
+1K182458Longterm NPWT Foam Dressing KitZhejiang Longterm Medical Technology Co., Ltd.20190—
+1K132225ExtricareDevon Medical, Inc.20148—
+1K132936Novopore DressingPolynovo Biomaterials Pty, Ltd.20140—
+1K122490KulavacCG Bio Co., Ltd.20130—
+1K080357Medela Invia Wound TherapyMedela AG2008751
+1K063692V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000Kci USA, Inc.2007601
+1K063740V.a.C. Therapy Systems - Info V.a.C. Therapy Uniy, Model M6257766Kci USA, Inc.200714
+1K063590V.a.C. Freedom Canister, Model M6275421; V.a.C. Ats Canister, Models K6275422, M6275423Kci USA, Inc.20070—
+1K063426V.a.C. Ats Large (1000 ML) Canister with Gel, Models M6275093/5, M6275093/10Kci USA, Inc.20062—
+1K062227V.a.C. Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)200632
+1K050261V.a.C. Granufoam Silver Protection DressingKinetic Concepts, Inc.20057—
+1K050129Celleration Mist Therapy System 5.1Celleration, Inc.20056—
+1K041642V.a.C. Granufoam Silver DressingKinetic Concepts, Inc.20058—
+2K241023Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc.20240—
+2K221223extriCARE® 3000 Negative Wound Pressure Therapy SystemAlleva Medical Devices20230—
+2K202898Tzoar 207 Negative Pressure Wound Therapy (NPWT) SystemLightstone Medical Products (Ningbo) Co, Ltd.20210—
+2K183543ACTIV.A.C. Therapy UnitKci USA, Inc.201941
+2K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc.20160—
+2K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC20160—
+2K142626Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set…Medela AG201512—
+2K141926Invia Endure Negative Pressure Wound Therapy SystemMedela AG20145—
+2K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…Devon Medical, Inc.20144—
+2K141033Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG…Argentum Medical, LLC20140—
+2K121817Vcare aIVT Medical, Ltd.20130—
+2K113236Foryou NPWT DeviceForyou Medical Electronics Co, Ltd.20130—
+2K113678Invia Motion Negative Pressure Wound Therapy SystemMedela AG201211—
+2K113291Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and…Simex Medizintechnik GmbH20124—
+2K100823Wound Pro ApexAccuro Medical Products, LLC2011101
+2K093526V.a.C. Via Therapy System, V.a.C. Via Negative Pressure Therapy Unit, V.a.C. Via…Kci USA, Inc. (Kinetic Concepts, Inc.)201017—
+2K091038AS 1000 Ultrasound Wound Therapy SystemArobella Medical, LLC20090—
+2K083357Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510Kci USA, Inc.20091—
+2K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc.2009562
+2K080275NPD 1000 Negative Pressure Wound Therapy SystemIasis Medical, Inc.200837—
+2K062544AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC200751
+2K053627Modification to: V.a.C. Granufoam Silver Protection DressingKci USA, Inc.20065—
+3K230233Prospera Spectruum Negative Pressure Wound Therapy SystemDeroyal Industries, Inc.20240—
+3K201571ACTIV.A.C. Negative Pressure Wound Therapy SystemKci USA, Inc.20203—
+3K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG20183—
+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
+3K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days…Medela AG201641
+3K152163Renasys GOSmith & Nephew, Inc.20160—
+3K153209RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH…Smith & Nephew Medical, Ltd.20165—
+3K151872Avance Y-Connector SMolnlycke Health Care Us, LLC20152—
+3K141255Simex Subglottic Aspiration SystemSimex Medizintechnik GmbH20143—
+3K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC20140—
+3K132741V.a.C. Via Negative Pressure Wound Therapy SystemKci USA, Inc.20134—
+3K120499Abthera Open Abdomen Negative Pressure Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)20120—
+3K111949AC Wound Treatment SystemNanovibronix, Inc.20120—
+3K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc.201225—
+3K110078ExtricareDevon Medical Products, Inc.20129—
+3K111170PICOSmith & Nephew, Inc.201126—
+3K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc.20112—
+3K102956V.a.C. Granufoam Silver Small Dressing; V.a.C. Granufoam Silver Medium Dressing; V.a.C.…Kci USA, Inc. (Kinetic Concepts, Inc.)20100—
+3K091470Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc.2009151
+3K072904Sonoca 180/195 Wound Care SystemSoering GmbH20081—
+4K253199Curasys 2 (EMDN0003)CG Bio Co., Ltd.20260—
+4K254019Wound Geni NPWT SystemBechtel Medical, Inc.20260—
+4K241515NEXA™ NPWT SystemNexa Medical Limited20240—
+4K2411343M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)Kci USA, Inc.20240—
+4K223388Invia® Integrated DressingMedela AG20230—
+4K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG20220—
+4K202823Innomed NPWT Silicone Foam DressingZhejiang Longterm Medical Technology Co., Ltd.20210—
+4K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited20193—
+4K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC20192—
+4K181204RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited20190—
+4K180415Invia White Foam NPWTMedela AG20180—
+4K173447V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative…Kci USA, Inc.20180—
+4K162610NEXA Negative Pressure Wound Therapy SystemNexa Medical, Ltd.20170—
+4K163387PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited201711—
+4K161432MyNeWT Negative Pressure Wound Therapy SystemStortford Medical, LLC20170—
+4K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC20160—
+4K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd.20162—
+4K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd.201623—
+4K123980Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc.20130—
+4K102001Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc.2010143
+5K223041Renasys Edge (66803126)Smith & Nephew Medical Limited202223
+5K203369Avance Solo Negative Pressure Wound Therapy (NPWT) SystemMolnlycke Health Care Us, LLC20210—
+5K200223PocketDoc™ Micro Wound Therapy SystemPensar Medical, LLC20200—
+5K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC20191—
+5K180840UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20183—
+5K180205AVELLE Negative Pressure Wound Therapy SystemConvatec Limited20183—
+5K180991AG 100sHospitech Respiration, Ltd.20181—
+5K180698PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20186—
+5K172005PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20188—
+5K172521PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20171—
+5K172519PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20170—
+5K161599UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20174—
+5K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…Smith & Nephew, Inc.20155—
+5K142979RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft…Smith & Nephew, Inc.2015121
+5K132446Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.201313—
+6K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building20260—
+6K243576RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze…Smith & Nephew Medical, Ltd.20251—
+6K231939Renasys EdgeSmith & Nephew Medical, Ltd.20241—
+6K221477AG100sHospitech Respiration, Ltd.20220—
+6K212359PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC20220—
+6K202783Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film DressingSmith & Nephew Medical Limited20220—
+6K202157PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative…Smith & Nephew Medical Limited20201—
+6K190028UNO 30Genadyne Biotechnologies20201—