510(k) Report

Devices descending from K021501

30 later devices reach V.a.C. Instillamat (Vacuum Assisted Closure Instillamat through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100657V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy System) Model…Kci USA, Inc. (Kinetic Concepts, Inc.)201019—
+1K071301Antlia I Wound Irrigation SystemInnovative Therapies, Inc.20073—
+1K062227V.a.C. Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)200632
+1K060046DermastreamEnzysurge, Ltd.20061—
+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—
+2K121817Vcare aIVT Medical, Ltd.20130—
+2K103156V.a.C. Veraflo Cleanse Dressing SystemKci USA, Inc. (Kinetic Concepts, Inc.)20113—
+2K093564Sved Wound Treatment SystemInnovative Therapies, Inc.20092—
+2K091133Aplion Topical Care SystemAplion Medical,Llc20090—
+2K083357Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510Kci USA, Inc.20091—
+3K233614Genadyne DUO NPWTGenadyne Biotechnologies, Inc.20240—
+3K203316V.A.C.ULTA Negative Pressure Wound Therapy SystemKci, A Part of 3M Health Care Business Group20211—
+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—
+3K142916SVED Wound Treatment SystemCardinalhealth20151—
+3K120499Abthera Open Abdomen Negative Pressure Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)20120—
+4K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.20260—
+4K231646Carilex VT¿200-i NXCarilex Medical, Inc.20240—
+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—
+4K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemKci USA, Inc.20185—
+4K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemKci USA, Inc.20187—
+5K2215853M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete…3M Healthcare Business Group20230—
+5K223263Prevena Plus 125 Therapy Unit3M202301
+5K220660Prevena Restor Adapti-Form Dressing3M Healthcare Business Group20220—
+5K202217Kendall NPWT Incision Management DeviceCardinalhealth20210—
+5K191101Kendall NPWT Incision Management Dressing KitCardinalhealth20200—