510(k) Report

Devices descending from K945062

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K111333Antlia Iii Wound Treatment SystemInnovative Therapies, Inc.20115—
+4K103156V.a.C. Veraflo Cleanse Dressing SystemKci USA, Inc. (Kinetic Concepts, Inc.)20113—
+4K092992A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc.201031—
+4K093526V.a.C. Via Therapy System, V.a.C. Via Negative Pressure Therapy Unit, V.a.C. Via…Kci USA, Inc. (Kinetic Concepts, Inc.)201017—
+4K093564Sved Wound Treatment SystemInnovative Therapies, Inc.20092—
+4K091470Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc.2009151
+4K091133Aplion Topical Care SystemAplion Medical,Llc20090—
+4K090638Genadyne A4-XLR8 Wound Vacuum SystemGenadyne Biotechnologies, Inc.20092—
+4K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc.2009562
+4K080275NPD 1000 Negative Pressure Wound Therapy SystemIasis Medical, Inc.200837—
+4K072904Sonoca 180/195 Wound Care SystemSoering GmbH20081—
+4K053627Modification to: V.a.C. Granufoam Silver Protection DressingKci USA, Inc.20065—
+5K251826RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologySmith & Nephew Medical, Ltd.20250—
+5K243187Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)Cork Medical20251—
+5K233614Genadyne DUO NPWTGenadyne Biotechnologies, Inc.20240—
+5K230233Prospera Spectruum Negative Pressure Wound Therapy SystemDeroyal Industries, Inc.20240—
+5K231646Carilex VT¿200-i NXCarilex Medical, Inc.20240—
+5K230677Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)Cork Medical20231—
+5K202823Innomed NPWT Silicone Foam DressingZhejiang Longterm Medical Technology Co., Ltd.20210—
+5K203316V.A.C.ULTA Negative Pressure Wound Therapy SystemKci, A Part of 3M Health Care Business Group20211—
+5K203693Nisus Touch Negative Pressure Wound Therapy PumpCork Medical Products, LLC20210—
+5K201571ACTIV.A.C. Negative Pressure Wound Therapy SystemKci USA, Inc.20203—
+5K190119Foryou NPWT Dressing Kit4l Health Co., Ltd.20190—
+5K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited20193—
+5K182191Invia Abdominal Dressing KitMedela AG20190—
+5K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC20192—
+5K181204RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited20190—
+5K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+5K180415Invia White Foam NPWTMedela AG20180—
+5K180991AG 100sHospitech Respiration, Ltd.20181—
+5K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG20183—
+5K161420Moves SLCThornhill Research, Inc.20170—
+5K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+5K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days…Medela AG201641
+5K161939Avance Abdominal Dressing KitMolnlycke Health Care Us, LLC20161—
+5K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC20160—
+5K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsKci USA, Inc. (Kinetic Concepts, Inc.)20168—
+5K152163Renasys GOSmith & Nephew, Inc.20160—
+5K160451V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...Kci USA, Inc. (Kinetic Concepts, Inc.)20162—
+5K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus…Kci USA, Inc.20169—
+5K152741Mepiseal Soft Silicone SealantMolnlycke Health Care Us, LLC20160—
+5K151872Avance Y-Connector SMolnlycke Health Care Us, LLC20152—
+5K143726XLR8 Plus (XLR8+)Genadyne Biotechnologies, Inc.20150—
+5K142646XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit andGenadyne Biotechnologies, Inc.20151—
+5K143016Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at HomeCardinalhealth201542
+5K141961Genadyne Spiro Foam Dressing KitGenadyne Biotechnologies, Inc.20150—
+5K142916SVED Wound Treatment SystemCardinalhealth20151—
+5K133333Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing KitBlue Ocean Medical Product, LLC20144—
+5K141437XLR8 Plus (XLR8+)Genadyne Biotechnologies, Inc.20140—
+5K132741V.a.C. Via Negative Pressure Wound Therapy SystemKci USA, Inc.20134—
+5K123980Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc.20130—
+5K113199Kevo NPWT-AHEMO30 and a HEMO45 Foam Dressing KitKevo Medical Supplies201210—
+5K111949AC Wound Treatment SystemNanovibronix, Inc.20120—
+5K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc.201225—
+5K111170PICOSmith & Nephew, Inc.201126—
+5K102956V.a.C. Granufoam Silver Small Dressing; V.a.C. Granufoam Silver Medium Dressing; V.a.C.…Kci USA, Inc. (Kinetic Concepts, Inc.)20100—
+5K102001Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc.2010143
+6K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.20260—
+6K253199Curasys 2 (EMDN0003)CG Bio Co., Ltd.20260—
+6K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical20260—
+6K254019Wound Geni NPWT SystemBechtel Medical, Inc.20260—
+6K241061VERSA Negative Pressure Wound Therapy System (VCMPP-100)Cork Medical20240—
+6K241515NEXA™ NPWT SystemNexa Medical Limited20240—
+6K2411343M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)Kci USA, Inc.20240—
+6K223388Invia® Integrated DressingMedela AG20230—
+6K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+6K221477AG100sHospitech Respiration, Ltd.20220—
+6K223041Renasys Edge (66803126)Smith & Nephew Medical Limited202223
+6K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG20220—
+6K2115213M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large…3M Healthcare Business Group20211—
+6K190697PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management…Kci USA, Inc.20190—
+6K182722XLR8 Abdominal Wound Dressing KitGenadyne Biotechnologies20190—
+6K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC20191—
+6K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+6K181507PREVENA RESTOR (TM) Incision Management SystemKci USA, Inc.20191—
+6K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemKci USA, Inc.20185—
+6K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemKci USA, Inc.20187—
+6K173447V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative…Kci USA, Inc.20180—
+6K162610NEXA Negative Pressure Wound Therapy SystemNexa Medical, Ltd.20170—
+6K163387PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited201711—
+6K161432MyNeWT Negative Pressure Wound Therapy SystemStortford Medical, LLC20170—
+6K161570Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium…Lc Medical Concepts, Inc.20162—
+6K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd.201623—
+6K150459FloSure Ventilation PatchSimex Medizintechnik GmbH20160—
+6K151261Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit…Medela AG20159—
+6K150124Cardinal Health NPWT PRO HCCardinalhealth20153—
+6K132446Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.201313—
+7K231939Renasys EdgeSmith & Nephew Medical, Ltd.20241—
+7K2215853M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete…3M Healthcare Business Group20230—
+7K223263Prevena Plus 125 Therapy Unit3M202301
+7K212359PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC20220—
+7K220660Prevena Restor Adapti-Form Dressing3M Healthcare Business Group20220—
+7K211277Theia NPWT Foam Wound Dressing KitClear Choice Therapeutics, Inc.20211—
+7K203369Avance Solo Negative Pressure Wound Therapy (NPWT) SystemMolnlycke Health Care Us, LLC20210—
+7K202217Kendall NPWT Incision Management DeviceCardinalhealth20210—
+7K200223PocketDoc™ Micro Wound Therapy SystemPensar Medical, LLC20200—
+7K191101Kendall NPWT Incision Management Dressing KitCardinalhealth20200—
+7K180840UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20183—
+7K180205AVELLE Negative Pressure Wound Therapy SystemConvatec Limited20183—
+7K180698PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20186—