510(k) Report

Devices descending from K061435

120 later devices reach Medela Vario Suction Pumps through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153663Vario 8/18/ciMedela AG20161—
+1K093261MOVESThornhill Research, Inc.20107Class I
+1K070904Antlia II Suction Pump SystemInnovative Therapies, Inc.2007109—
+2K221676ExsaltaDrw Medical20220—
+2K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+2K140049Moves SLCThornhill Research, Inc.20141—
+2K111333Antlia Iii Wound Treatment SystemInnovative Therapies, Inc.20115—
+2K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc.2009562
+2K082211Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc.2008681
+3K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+3K161420Moves SLCThornhill Research, Inc.20170—
+3K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+3K152163Renasys GOSmith & Nephew, Inc.20160—
+3K143016Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at HomeCardinalhealth201542
+3K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…Devon Medical, Inc.20144—
+3K132225ExtricareDevon Medical, Inc.20148—
+3K122490KulavacCG Bio Co., Ltd.20130—
+3K113678Invia Motion Negative Pressure Wound Therapy SystemMedela AG201211—
+3K111949AC Wound Treatment SystemNanovibronix, Inc.20120—
+3K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc.201225—
+3K111170PICOSmith & Nephew, Inc.201126—
+3K110647Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound…Smith & Nephew, Inc.2011486
+3K092992A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc.201031—
+3K091470Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc.2009151
+4K241023Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc.20240—
+4K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+4K221223extriCARE® 3000 Negative Wound Pressure Therapy SystemAlleva Medical Devices20230—
+4K202898Tzoar 207 Negative Pressure Wound Therapy (NPWT) SystemLightstone Medical Products (Ningbo) Co, Ltd.20210—
+4K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+4K162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC20173—
+4K163387PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited201711—
+4K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Medela AG201781
+4K161432MyNeWT Negative Pressure Wound Therapy SystemStortford Medical, LLC20170—
+4K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days…Medela AG201641
+4K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd.201623—
+4K150124Cardinal Health NPWT PRO HCCardinalhealth20153—
+4K142646XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit andGenadyne Biotechnologies, Inc.20151—
+4K142979RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft…Smith & Nephew, Inc.2015121
+4K141961Genadyne Spiro Foam Dressing KitGenadyne Biotechnologies, Inc.20150—
+4K143301NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA KitIntegrated Healing Technologies20150—
+4K142956NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome KitIntegrated Healing Technologies20150—
+4K133333Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing KitBlue Ocean Medical Product, LLC20144—
+4K141926Invia Endure Negative Pressure Wound Therapy SystemMedela AG20145—
+4K140022Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus NPWT…Cork Medical Products, LLC20145—
+4K132004NPWT Wound Dressing Kit- Medium, NPWT Wound Dressing Kit- LargeCreo Quality, LLC20141—
+4K132936Novopore DressingPolynovo Biomaterials Pty, Ltd.20140—
+4K123507Kci NPWT Gauze DressingKci USA, Inc.201311—
+4K122132Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large)…Molnlycke Health Care201321—
+4K113199Kevo NPWT-AHEMO30 and a HEMO45 Foam Dressing KitKevo Medical Supplies201210—
+4K110078ExtricareDevon Medical Products, Inc.20129—
+4K112784Renasys AB Abominal Dressing KitSmith & Nephew, Inc.201110—
+4K102001Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc.2010143
+5K243187Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)Cork Medical20251—
+5K243576RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze…Smith & Nephew Medical, Ltd.20251—
+5K230677Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)Cork Medical20231—
+5K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitZhejiang Longterm Medical Technology Co., Ltd.20220—
+5K202783Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film DressingSmith & Nephew Medical Limited20220—
+5K202823Innomed NPWT Silicone Foam DressingZhejiang Longterm Medical Technology Co., Ltd.20210—
+5K203693Nisus Touch Negative Pressure Wound Therapy PumpCork Medical Products, LLC20210—
+5K203369Avance Solo Negative Pressure Wound Therapy (NPWT) SystemMolnlycke Health Care Us, LLC20210—
+5K200223PocketDoc™ Micro Wound Therapy SystemPensar Medical, LLC20200—
+5K182458Longterm NPWT Foam Dressing KitZhejiang Longterm Medical Technology Co., Ltd.20190—
+5K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC20192—
+5K180840UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20183—
+5K180415Invia White Foam NPWTMedela AG20180—
+5K180205AVELLE Negative Pressure Wound Therapy SystemConvatec Limited20183—
+5K180698PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20186—
+5K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG20183—
+5K172005PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20188—
+5K171499Occlusion Detection Dressing KitCardinalhealth20170—
+5K172521PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20171—
+5K172519PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20170—
+5K161599UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20174—
+5K161418Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery SetCardinalhealth20171—
+5K162129RENASYS-G Gauze Dressing Kits with Soft PortSmith & Nephew, Inc.20160—
+5K161570Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium…Lc Medical Concepts, Inc.20162—
+5K153209RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH…Smith & Nephew Medical, Ltd.20165—
+5K151263Venturi Gauze Wound Care Sets with Portal DrainTalley Group, Ltd.20161—
+5K150459FloSure Ventilation PatchSimex Medizintechnik GmbH20160—
+5K151261Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit…Medela AG20159—
+5K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…Smith & Nephew, Inc.20155—
+5K151326RENASYS¿ EZ PLUS Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.20150—
+5K141847Avance Foam Dressing KitsMolnlycke Health Care Us, LLC201514—
+5K130852Avance® Foam Abdominal Dressing KitMolnlycke Health Care20143—
+5K132446Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.201313—
+6K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.20260—
+6K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building20260—
+6K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical20260—
+6K254019Wound Geni NPWT SystemBechtel Medical, Inc.20260—
+6K251826RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologySmith & Nephew Medical, Ltd.20250—
+6K241061VERSA Negative Pressure Wound Therapy System (VCMPP-100)Cork Medical20240—
+6K223388Invia® Integrated DressingMedela AG20230—
+6K212359PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC20220—
+6K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG20220—
+6K211277Theia NPWT Foam Wound Dressing KitClear Choice Therapeutics, Inc.20211—
+6K202157PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative…Smith & Nephew Medical Limited20201—
+6K190028UNO 30Genadyne Biotechnologies20201—
+6K191760PICO 14 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20192—
+6K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC20191—
+6K181929MiMo (TM) Negative Pressure Wound Therapy SystemBaymax Research, Inc.20190—