510(k) Report

Devices descending from K121883

14 later devices reach Prevena Incision Management System with Customizable Dressing, Prevena… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150006Prevena Incision Management System with Peel & Place Dressing, Prevena Incision…Kci USA, Inc.20150—
+1K123878Prevena Incision Management System with Customizable DressingKci USA, Inc. (Kinetic Concepts, Inc.)2013128
+2K141017Prevena Incision Management System with Peel & Dressing, Prevena Incision Management…Kci USA, Inc. (Kinetic Concepts, Inc.)201510—
+2K133232Prevena Incision Management System with Customizable Dressing, Prevena Incision…Kci USA, Inc. (Kinetic Concepts, Inc.)20140—
+3K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsKci USA, Inc. (Kinetic Concepts, Inc.)20168—
+3K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus…Kci USA, Inc.20169—
+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—
+5K223263Prevena Plus 125 Therapy Unit3M202301
+5K220660Prevena Restor Adapti-Form Dressing3M Healthcare Business Group20220—
+5K202217Kendall NPWT Incision Management DeviceCardinalhealth20210—
+5K191101Kendall NPWT Incision Management Dressing KitCardinalhealth20200—