510(k) Report

Devices descending from K100821

67 later devices reach Prevena Incision Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141017Prevena Incision Management System with Peel & Dressing, Prevena Incision Management…Kci USA, Inc. (Kinetic Concepts, Inc.)201510—
+1K133232Prevena Incision Management System with Customizable Dressing, Prevena Incision…Kci USA, Inc. (Kinetic Concepts, Inc.)20140—
+1K133137Cisnap Closed Incision SystemSpiracur, Inc.20140—
+1K121883Prevena Incision Management System with Customizable Dressing, Prevena Customizable…Kci USA, Inc. (Kinetic Concepts, Inc.)201214—
+1K120033Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom…Kci USA, Inc.201225—
+1K111170PICOSmith & Nephew, Inc.201126—
+2K203369Avance Solo Negative Pressure Wound Therapy (NPWT) SystemMolnlycke Health Care Us, LLC20210—
+2K183543ACTIV.A.C. Therapy UnitKci USA, Inc.201941
+2K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG20183—
+2K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc.20160—
+2K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsKci USA, Inc. (Kinetic Concepts, Inc.)20168—
+2K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus…Kci USA, Inc.20169—
+2K150006Prevena Incision Management System with Peel & Place Dressing, Prevena Incision…Kci USA, Inc.20150—
+2K133276V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing, Granufoam…Kci USA, Inc.20139—
+2K132741V.a.C. Via Negative Pressure Wound Therapy SystemKci USA, Inc.20134—
+2K123878Prevena Incision Management System with Customizable DressingKci USA, Inc. (Kinetic Concepts, Inc.)2013128
+2K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc.201225—
+3K254019Wound Geni NPWT SystemBechtel Medical, Inc.20260—
+3K250586Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…Deroyal Industries, Inc.20250—
+3K241515NEXA™ NPWT SystemNexa Medical Limited20240—
+3K230233Prospera Spectruum Negative Pressure Wound Therapy SystemDeroyal Industries, Inc.20240—
+3K223388Invia® Integrated DressingMedela AG20230—
+3K213853RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing LargeSmith and Nephew Medical Limited20231—
+3K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG20220—
+3K201571ACTIV.A.C. Negative Pressure Wound Therapy SystemKci USA, Inc.20203—
+3K190697PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management…Kci USA, Inc.20190—
+3K181505V.A.C. DERMATAC DrapeKci USA, Inc.20195—
+3K181507PREVENA RESTOR (TM) Incision Management SystemKci USA, Inc.20191—
+3K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemKci USA, Inc.20185—
+3K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemKci USA, Inc.20187—
+3K173447V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative…Kci USA, Inc.20180—
+3K162610NEXA Negative Pressure Wound Therapy SystemNexa Medical, Ltd.20170—
+3K163387PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited201711—
+3K161432MyNeWT Negative Pressure Wound Therapy SystemStortford Medical, LLC20170—
+3K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd.201623—
+4K253199Curasys 2 (EMDN0003)CG Bio Co., Ltd.20260—
+4K2411343M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)Kci USA, Inc.20240—
+4K223263Prevena Plus 125 Therapy Unit3M202301
+4K220660Prevena Restor Adapti-Form Dressing3M Healthcare Business Group20220—
+4K202823Innomed NPWT Silicone Foam DressingZhejiang Longterm Medical Technology Co., Ltd.20210—
+4K212320Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small…3M Healthcare Business Group20211—
+4K202217Kendall NPWT Incision Management DeviceCardinalhealth20210—
+4K200223PocketDoc™ Micro Wound Therapy SystemPensar Medical, LLC20200—
+4K191101Kendall NPWT Incision Management Dressing KitCardinalhealth20200—
+4K200390V.A.C. DERMATAC DrapeKci USA, Inc.20202—
+4K180840UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20183—
+4K180205AVELLE Negative Pressure Wound Therapy SystemConvatec Limited20183—
+4K180698PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20186—
+4K172005PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20188—
+4K172521PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20171—
+4K172519PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20170—
+4K161599UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20174—
+5K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building20260—
+5K2215853M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete…3M Healthcare Business Group20230—
+5K2228593M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place…3M20230—
+5K212359PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC20220—
+5K220560Dermatac Drape3M20220—
+5K202157PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative…Smith & Nephew Medical Limited20201—
+5K190028UNO 30Genadyne Biotechnologies20201—
+5K191760PICO 14 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20192—
+5K181929MiMo (TM) Negative Pressure Wound Therapy SystemBaymax Research, Inc.20190—
+5K182323PICO 7Y Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20190—
+5K180614PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20180—
+6K213906extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd.20231—
+6K221891UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20220—
+6K211318PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative…Smith Nephew Medical Limited20220—
+7K251646extriCARE® 1000 Negative Pressure Wound Therapy SystemAlleva Medical Devices20250—