510(k) Report

Devices descending from K061205

85 later devices reach Medela Vario 8/18/CI Secretion & Surgical Aspirator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161420Moves SLCThornhill Research, Inc.20170—
+1K153663Vario 8/18/ciMedela AG20161—
+1K141255Simex Subglottic Aspiration SystemSimex Medizintechnik GmbH20143—
+1K080357Medela Invia Wound TherapyMedela AG2008751
+1K080212Medela Thopaz, Model 200 0288Medela AG20085—
+2K221676ExsaltaDrw Medical20220—
+2K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC20160—
+2K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd.20162—
+2K142626Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set…Medela AG201512—
+2K141926Invia Endure Negative Pressure Wound Therapy SystemMedela AG20145—
+2K130210Medela ThopazMedela AG20132—
+2K113678Invia Motion Negative Pressure Wound Therapy SystemMedela AG201211—
+2K113291Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and…Simex Medizintechnik GmbH20124—
+2K103042Atmos E 201 Thorax and Atmos S 201 ThoraxAtmos, Inc.20111—
+2K100823Wound Pro ApexAccuro Medical Products, LLC2011101
+2K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc.2009562
+3K241799ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system…Atmos Medizintechnik GmbH & Co. KG20250—
+3K180991AG 100sHospitech Respiration, Ltd.20181—
+3K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG20183—
+3K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Medela AG201781
+3K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days…Medela AG201641
+3K152163Renasys GOSmith & Nephew, Inc.20160—
+3K153209RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH…Smith & Nephew Medical, Ltd.20165—
+3K151872Avance Y-Connector SMolnlycke Health Care Us, LLC20152—
+3K141553Medela Thopaz+Medela AG20141—
+3K132225ExtricareDevon Medical, Inc.20148—
+3K111949AC Wound Treatment SystemNanovibronix, Inc.20120—
+3K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc.201225—
+3K111170PICOSmith & Nephew, Inc.201126—
+3K091470Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc.2009151
+4K254019Wound Geni NPWT SystemBechtel Medical, Inc.20260—
+4K241023Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc.20240—
+4K223388Invia® Integrated DressingMedela AG20230—
+4K221223extriCARE® 3000 Negative Wound Pressure Therapy SystemAlleva Medical Devices20230—
+4K221477AG100sHospitech Respiration, Ltd.20220—
+4K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG20220—
+4K202898Tzoar 207 Negative Pressure Wound Therapy (NPWT) SystemLightstone Medical Products (Ningbo) Co, Ltd.20210—
+4K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited20193—
+4K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC20192—
+4K181204RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited20190—
+4K181667Thoraguard SystemCentese, Inc.20180—
+4K180415Invia White Foam NPWTMedela AG20180—
+4K163387PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited201711—
+4K161432MyNeWT Negative Pressure Wound Therapy SystemStortford Medical, LLC20170—
+4K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC20160—
+4K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd.201623—
+4K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…Devon Medical, Inc.20144—
+4K102001Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc.2010143
+5K223041Renasys Edge (66803126)Smith & Nephew Medical Limited202223
+5K202823Innomed NPWT Silicone Foam DressingZhejiang Longterm Medical Technology Co., Ltd.20210—
+5K203369Avance Solo Negative Pressure Wound Therapy (NPWT) SystemMolnlycke Health Care Us, LLC20210—
+5K200223PocketDoc™ Micro Wound Therapy SystemPensar Medical, LLC20200—
+5K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC20191—
+5K180840UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20183—
+5K180205AVELLE Negative Pressure Wound Therapy SystemConvatec Limited20183—
+5K180698PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20186—
+5K172005PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20188—
+5K172521PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20171—
+5K172519PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20170—
+5K162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC20173—
+5K161599UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20174—
+5K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…Smith & Nephew, Inc.20155—
+5K142979RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft…Smith & Nephew, Inc.2015121
+5K132446Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.201313—
+6K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building20260—
+6K243576RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze…Smith & Nephew Medical, Ltd.20251—
+6K231939Renasys EdgeSmith & Nephew Medical, Ltd.20241—
+6K212359PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC20220—
+6K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitZhejiang Longterm Medical Technology Co., Ltd.20220—
+6K202783Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film DressingSmith & Nephew Medical Limited20220—
+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—
+6K182458Longterm NPWT Foam Dressing KitZhejiang Longterm Medical Technology Co., Ltd.20190—
+6K181929MiMo (TM) Negative Pressure Wound Therapy SystemBaymax Research, Inc.20190—
+6K182323PICO 7Y Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20190—
+6K180614PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20180—
+6K162129RENASYS-G Gauze Dressing Kits with Soft PortSmith & Nephew, Inc.20160—
+6K151326RENASYS¿ EZ PLUS Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.20150—
+7K260646Renasys Edge (66803126)Smith & Nephew Medical, Ltd.20260—
+7K251826RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologySmith & Nephew Medical, Ltd.20250—
+7K213906extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd.20231—
+7K221891UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20220—
+7K211318PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative…Smith Nephew Medical Limited20220—
+8K251646extriCARE® 1000 Negative Pressure Wound Therapy SystemAlleva Medical Devices20250—