510(k) Report

Devices descending from K021368

119 later devices reach Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130123Basic and Dominant Flex Suction PumpsMedela AG20134—
+1K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+1K072870Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc.200811—
+1K063336Medela Dominant 50 Lipo, Model 600-5706Medela AG20074—
+1K052626Smartsuction Harmony DeviceHaemonetics Corp.200511
+1K043544Medela Dominant 35 C/I Secretion and Surgical AspiratorMedela AG200593—
+1K042943Nouvag AG - Vacuson 40 and Vacuson 60Nouvag AG20042—
+1K041405Aspiration Pump, Model Imd-020Industrial & Medical Design, Inc.20040—
+2K260892Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd.20260—
+2K181941Swift SystemEmblation, Ltd.20183—
+2K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+2K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+2K150134Basic, Dominant Flex, KV-6Medela AG20152—
+2K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+2K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+2K092903Bora UP 2080, Bora UP 2080 OP and Bora UP 2080 MountingMaquet GmbH and Co. KG20090—
+2K082819Dermatologic Treatment System (DTS) G2Miramar Labs, Inc.200910—
+2K090445Atmos C361/C451 Suction PumpAtmos, Inc.20090—
+2K082025Body-JetHuman Med AG200801
+2K080212Medela Thopaz, Model 200 0288Medela AG20085—
+2K062801Smartsuction Solo DeviceHaemonetics Corp.20060—
+2K061205Medela Vario 8/18/CI Secretion & Surgical AspiratorMedela AG2006851
+3K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited20250—
+3K222388swiftPro SystemEmblation, Ltd.20232—
+3K190669EndoticsEra Endoscopy S.R.L.20200—
+3K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+3K161420Moves SLCThornhill Research, Inc.20170—
+3K160950MiniscavSedation Systems, LLC201701
+3K170329Basic, Dominant FlexModela AG201701
+3K153663Vario 8/18/ciMedela AG20161—
+3K141255Simex Subglottic Aspiration SystemSimex Medizintechnik GmbH20143—
+3K130210Medela ThopazMedela AG20132—
+3K103042Atmos E 201 Thorax and Atmos S 201 ThoraxAtmos, Inc.20111—
+3K103014Miradry SystemMiramar Labs, Inc.201152
+3K080357Medela Invia Wound TherapyMedela AG2008751
+4K241799ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system…Atmos Medizintechnik GmbH & Co. KG20250—
+4K240518swiftPro™ SystemEmblation Limited20241—
+4K221676ExsaltaDrw Medical20220—
+4K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC20160—
+4K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd.20162—
+4K142626Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set…Medela AG201512—
+4K141511SIDELAZE800 Laser Beam Delivery Accessory for Cynosure 1440MM Wavelength LasersCynosure, Inc.20150—
+4K141926Invia Endure Negative Pressure Wound Therapy SystemMedela AG20145—
+4K141553Medela Thopaz+Medela AG20141—
+4K131162Miradry SystemMiramar Labs, Inc.201331
+4K113678Invia Motion Negative Pressure Wound Therapy SystemMedela AG201211—
+4K113291Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and…Simex Medizintechnik GmbH20124—
+4K100823Wound Pro ApexAccuro Medical Products, LLC2011101
+4K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc.2009562
+5K181667Thoraguard SystemCentese, Inc.20180—
+5K180991AG 100sHospitech Respiration, Ltd.20181—
+5K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG20183—
+5K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Medela AG201781
+5K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days…Medela AG201641
+5K152163Renasys GOSmith & Nephew, Inc.20160—
+5K153209RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH…Smith & Nephew Medical, Ltd.20165—
+5K151872Avance Y-Connector SMolnlycke Health Care Us, LLC20152—
+5K150419miraDry System MD4000Miramar Labs, Inc.201521
+5K132225ExtricareDevon Medical, Inc.20148—
+5K111949AC Wound Treatment SystemNanovibronix, Inc.20120—
+5K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc.201225—
+5K111170PICOSmith & Nephew, Inc.201126—
+5K091470Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc.2009151
+6K254019Wound Geni NPWT SystemBechtel Medical, Inc.20260—
+6K241023Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc.20240—
+6K223388Invia® Integrated DressingMedela AG20230—
+6K221223extriCARE® 3000 Negative Wound Pressure Therapy SystemAlleva Medical Devices20230—
+6K221477AG100sHospitech Respiration, Ltd.20220—
+6K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG20220—
+6K202898Tzoar 207 Negative Pressure Wound Therapy (NPWT) SystemLightstone Medical Products (Ningbo) Co, Ltd.20210—
+6K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited20193—
+6K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC20192—
+6K181204RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited20190—
+6K180415Invia White Foam NPWTMedela AG20180—
+6K163387PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited201711—
+6K161432MyNeWT Negative Pressure Wound Therapy SystemStortford Medical, LLC20170—
+6K160141miraDry SystemMiramar Labs, Inc.20161—
+6K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC20160—
+6K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd.201623—
+6K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…Devon Medical, Inc.20144—
+6K102001Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc.2010143
+7K223041Renasys Edge (66803126)Smith & Nephew Medical Limited202223
+7K202823Innomed NPWT Silicone Foam DressingZhejiang Longterm Medical Technology Co., Ltd.20210—
+7K203369Avance Solo Negative Pressure Wound Therapy (NPWT) SystemMolnlycke Health Care Us, LLC20210—
+7K200223PocketDoc™ Micro Wound Therapy SystemPensar Medical, LLC20200—
+7K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC20191—
+7K180840UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20183—
+7K180205AVELLE Negative Pressure Wound Therapy SystemConvatec Limited20183—
+7K180698PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20186—
+7K180396miraDry SystemMiramar Labs, Inc.20180—
+7K172005PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20188—
+7K172521PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20171—
+7K172519PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20170—
+7K162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC20173—
+7K161599UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20174—
+7K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…Smith & Nephew, Inc.20155—
+7K142979RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft…Smith & Nephew, Inc.2015121
+7K132446Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.201313—
+8K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building20260—
+8K243576RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze…Smith & Nephew Medical, Ltd.20251—