510(k) Report

Devices descending from K992448

150 later devices reach V.a.C. Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082311Exsudex Wound Drainage PumpThe Medical Company20080—
+1K032310Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc.20031122
+1K022011V.a.C. Abdominal DressingKinetic Concepts, Inc.2003171
+1K021500Vacuum Assisted ClosureKinetic Concepts, Inc.20020—
+1K021501V.a.C. Instillamat (Vacuum Assisted Closure InstillamatKinetic Concepts, Inc.200230—
+2K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitZhejiang Longterm Medical Technology Co., Ltd.20220—
+2K182458Longterm NPWT Foam Dressing KitZhejiang Longterm Medical Technology Co., Ltd.20190—
+2K132225ExtricareDevon Medical, Inc.20148—
+2K132936Novopore DressingPolynovo Biomaterials Pty, Ltd.20140—
+2K122490KulavacCG Bio Co., Ltd.20130—
+2K100657V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy System) Model…Kci USA, Inc. (Kinetic Concepts, Inc.)201019—
+2K100787Renasys F/-AB Abdominal Wound Dressing KitSmith & Nephew, Inc.201011—
+2K090489Abthera Open Abdomen Dressing, Model: M8275026Kci USA, Inc.20091—
+2K083357Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510Kci USA, Inc.20091—
+2K080357Medela Invia Wound TherapyMedela AG2008751
+2K063692V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000Kci USA, Inc.2007601
+2K063740V.a.C. Therapy Systems - Info V.a.C. Therapy Uniy, Model M6257766Kci USA, Inc.200714
+2K071301Antlia I Wound Irrigation SystemInnovative Therapies, Inc.20073—
+2K063590V.a.C. Freedom Canister, Model M6275421; V.a.C. Ats Canister, Models K6275422, M6275423Kci USA, Inc.20070—
+2K063426V.a.C. Ats Large (1000 ML) Canister with Gel, Models M6275093/5, M6275093/10Kci USA, Inc.20062—
+2K062227V.a.C. Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)200632
+2K060046DermastreamEnzysurge, Ltd.20061—
+2K050261V.a.C. Granufoam Silver Protection DressingKinetic Concepts, Inc.20057—
+2K050129Celleration Mist Therapy System 5.1Celleration, Inc.20056—
+2K041642V.a.C. Granufoam Silver DressingKinetic Concepts, Inc.20058—
+3K241023Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc.20240—
+3K221223extriCARE® 3000 Negative Wound Pressure Therapy SystemAlleva Medical Devices20230—
+3K202898Tzoar 207 Negative Pressure Wound Therapy (NPWT) SystemLightstone Medical Products (Ningbo) Co, Ltd.20210—
+3K183543ACTIV.A.C. Therapy UnitKci USA, Inc.201941
+3K162790V.A.C.ULTA Negative Pressure Wound Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)201731
+3K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc.20160—
+3K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC20160—
+3K141017Prevena Incision Management System with Peel & Dressing, Prevena Incision Management…Kci USA, Inc. (Kinetic Concepts, Inc.)201510—
+3K142626Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set…Medela AG201512—
+3K141926Invia Endure Negative Pressure Wound Therapy SystemMedela AG20145—
+3K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…Devon Medical, Inc.20144—
+3K141033Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG…Argentum Medical, LLC20140—
+3K121817Vcare aIVT Medical, Ltd.20130—
+3K113236Foryou NPWT DeviceForyou Medical Electronics Co, Ltd.20130—
+3K120499Abthera Open Abdomen Negative Pressure Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)20120—
+3K113678Invia Motion Negative Pressure Wound Therapy SystemMedela AG201211—
+3K113291Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and…Simex Medizintechnik GmbH20124—
+3K112784Renasys AB Abominal Dressing KitSmith & Nephew, Inc.201110—
+3K103156V.a.C. Veraflo Cleanse Dressing SystemKci USA, Inc. (Kinetic Concepts, Inc.)20113—
+3K100823Wound Pro ApexAccuro Medical Products, LLC2011101
+3K093526V.a.C. Via Therapy System, V.a.C. Via Negative Pressure Therapy Unit, V.a.C. Via…Kci USA, Inc. (Kinetic Concepts, Inc.)201017—
+3K093564Sved Wound Treatment SystemInnovative Therapies, Inc.20092—
+3K091038AS 1000 Ultrasound Wound Therapy SystemArobella Medical, LLC20090—
+3K091133Aplion Topical Care SystemAplion Medical,Llc20090—
+3K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc.2009562
+3K080275NPD 1000 Negative Pressure Wound Therapy SystemIasis Medical, Inc.200837—
+3K062544AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC200751
+3K053627Modification to: V.a.C. Granufoam Silver Protection DressingKci USA, Inc.20065—
+4K233614Genadyne DUO NPWTGenadyne Biotechnologies, Inc.20240—
+4K230233Prospera Spectruum Negative Pressure Wound Therapy SystemDeroyal Industries, Inc.20240—
+4K203316V.A.C.ULTA Negative Pressure Wound Therapy SystemKci, A Part of 3M Health Care Business Group20211—
+4K201571ACTIV.A.C. Negative Pressure Wound Therapy SystemKci USA, Inc.20203—
+4K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG20183—
+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
+4K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days…Medela AG201641
+4K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsKci USA, Inc. (Kinetic Concepts, Inc.)20168—
+4K152163Renasys GOSmith & Nephew, Inc.20160—
+4K153209RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH…Smith & Nephew Medical, Ltd.20165—
+4K160451V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...Kci USA, Inc. (Kinetic Concepts, Inc.)20162—
+4K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus…Kci USA, Inc.20169—
+4K151872Avance Y-Connector SMolnlycke Health Care Us, LLC20152—
+4K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…Smith & Nephew, Inc.20155—
+4K142916SVED Wound Treatment SystemCardinalhealth20151—
+4K141255Simex Subglottic Aspiration SystemSimex Medizintechnik GmbH20143—
+4K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC20140—
+4K130852Avance® Foam Abdominal Dressing KitMolnlycke Health Care20143—
+4K132741V.a.C. Via Negative Pressure Wound Therapy SystemKci USA, Inc.20134—
+4K111949AC Wound Treatment SystemNanovibronix, Inc.20120—
+4K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc.201225—
+4K110078ExtricareDevon Medical Products, Inc.20129—
+4K111170PICOSmith & Nephew, Inc.201126—
+4K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc.20112—
+4K102956V.a.C. Granufoam Silver Small Dressing; V.a.C. Granufoam Silver Medium Dressing; V.a.C.…Kci USA, Inc. (Kinetic Concepts, Inc.)20100—
+4K091470Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc.2009151
+4K072904Sonoca 180/195 Wound Care SystemSoering GmbH20081—
+5K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.20260—
+5K253199Curasys 2 (EMDN0003)CG Bio Co., Ltd.20260—
+5K254019Wound Geni NPWT SystemBechtel Medical, Inc.20260—
+5K241515NEXA™ NPWT SystemNexa Medical Limited20240—
+5K2411343M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)Kci USA, Inc.20240—
+5K231646Carilex VT¿200-i NXCarilex Medical, Inc.20240—
+5K223388Invia® Integrated DressingMedela AG20230—
+5K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG20220—
+5K2115213M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large…3M Healthcare Business Group20211—
+5K202823Innomed NPWT Silicone Foam DressingZhejiang Longterm Medical Technology Co., Ltd.20210—
+5K190697PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management…Kci USA, Inc.20190—
+5K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited20193—
+5K181507PREVENA RESTOR (TM) Incision Management SystemKci USA, Inc.20191—
+5K182191Invia Abdominal Dressing KitMedela AG20190—
+5K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC20192—
+5K181204RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited20190—
+5K180415Invia White Foam NPWTMedela AG20180—
+5K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemKci USA, Inc.20185—
+5K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemKci USA, Inc.20187—