510(k) Report

Devices descending from K091585

39 later devices reach Vac Therapy System, Models 340000, M8259999, 320000, M8259968 and 320100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113032Snap Wound Care SystemSpiracur, Inc.20110—
+1K100657V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy System) Model…Kci USA, Inc. (Kinetic Concepts, Inc.)201019—
+1K093526V.a.C. Via Therapy System, V.a.C. Via Negative Pressure Therapy Unit, V.a.C. Via…Kci USA, Inc. (Kinetic Concepts, Inc.)201017—
+2K162790V.A.C.ULTA Negative Pressure Wound Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)201731
+2K141017Prevena Incision Management System with Peel & Dressing, Prevena Incision Management…Kci USA, Inc. (Kinetic Concepts, Inc.)201510—
+2K132741V.a.C. Via Negative Pressure Wound Therapy SystemKci USA, Inc.20134—
+2K113678Invia Motion Negative Pressure Wound Therapy SystemMedela AG201211—
+2K103156V.a.C. Veraflo Cleanse Dressing SystemKci USA, Inc. (Kinetic Concepts, Inc.)20113—
+3K233614Genadyne DUO NPWTGenadyne Biotechnologies, Inc.20240—
+3K241515NEXA™ NPWT SystemNexa Medical Limited20240—
+3K203316V.A.C.ULTA Negative Pressure Wound Therapy SystemKci, A Part of 3M Health Care Business Group20211—
+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—
+3K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Medela AG201781
+3K161432MyNeWT Negative Pressure Wound Therapy SystemStortford Medical, LLC20170—
+3K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days…Medela AG201641
+3K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsKci USA, Inc. (Kinetic Concepts, Inc.)20168—
+3K160451V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...Kci USA, Inc. (Kinetic Concepts, Inc.)20162—
+3K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus…Kci USA, Inc.20169—
+3K141926Invia Endure Negative Pressure Wound Therapy SystemMedela AG20145—
+4K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.20260—
+4K2115213M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large…3M Healthcare Business Group20211—
+4K190697PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management…Kci USA, Inc.20190—
+4K181507PREVENA RESTOR (TM) Incision Management SystemKci USA, Inc.20191—
+4K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC20192—
+4K180415Invia White Foam NPWTMedela AG20180—
+4K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemKci USA, Inc.20185—
+4K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG20183—
+4K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemKci USA, Inc.20187—
+5K254019Wound Geni NPWT SystemBechtel Medical, Inc.20260—
+5K223388Invia® Integrated DressingMedela AG20230—
+5K2215853M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete…3M Healthcare Business Group20230—
+5K223263Prevena Plus 125 Therapy Unit3M202301
+5K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG20220—
+5K220660Prevena Restor Adapti-Form Dressing3M Healthcare Business Group20220—
+5K202217Kendall NPWT Incision Management DeviceCardinalhealth20210—
+5K191101Kendall NPWT Incision Management Dressing KitCardinalhealth20200—
+5K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC20191—
+6K212359PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC20220—