510(k) Report

Devices descending from K983552

187 later devices reach Basic, Median, Dominant, and Vario through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082311Exsudex Wound Drainage PumpThe Medical Company20080—
+1K061133Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30SNovaspine, LLC200618—
+1K061205Medela Vario 8/18/CI Secretion & Surgical AspiratorMedela AG2006851
+1K061435Medela Vario Suction PumpsMedela AG2006120—
+1K060963Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Monitor)Twin Star Medical20069—
+1K060277Boehringer Laboratories Suction Pump SystemBoehringer Laboratories200645—
+1K042134Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated20041592
+1K033179Medela Clario Home Care PumpMedela AG20030—
+1K011601Ardo Suction Pump Master, Model 30.00.XX; Ardo Suction Pump Senator, Model 31.00.XXArdo Medical AG20010—
+2K161420Moves SLCThornhill Research, Inc.20170—
+2K153663Vario 8/18/ciMedela AG20161—
+2K141255Simex Subglottic Aspiration SystemSimex Medizintechnik GmbH20143—
+2K133196Impact Model 323 AspiratorImpact Instrumentation, Inc.20140—
+2K131099AG MassHospitech Respiration, Ltd.20130—
+2K113291Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and…Simex Medizintechnik GmbH20124—
+2K110647Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound…Smith & Nephew, Inc.2011486
+2K093261MOVESThornhill Research, Inc.20107Class I
+2K090961Twin Star Compartment Pressure Monitor and Fluid Collection Catheter System (CMS-II)Twin Star Medical, Inc.20098—
+2K080275NPD 1000 Negative Pressure Wound Therapy SystemIasis Medical, Inc.200837—
+2K080357Medela Invia Wound TherapyMedela AG2008751
+2K080212Medela Thopaz, Model 200 0288Medela AG20085—
+2K080897Venturi Negative Pressure Wound Therapy SystemTalley Medical20084—
+2K070904Antlia II Suction Pump SystemInnovative Therapies, Inc.2007109—
+2K061919Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated20071071
+2K062456Novaspine Powered Suction Pump Pro-1Novaspine, LLC200616—
+2K061367Bluesky Vista Wound Vacuum System, Model 100.0500Blue Sky Medical Group Incorporated200624—
+2K061788Boehringer Laboratories Suction Pump SystemBoehringer Laboratories200655
+2K052456Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated2005127—
+2K050129Celleration Mist Therapy System 5.1Celleration, Inc.20056—
+3K221676ExsaltaDrw Medical20220—
+3K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC20160—
+3K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC20160—
+3K151263Venturi Gauze Wound Care Sets with Portal DrainTalley Group, Ltd.20161—
+3K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration, Ltd.20162—
+3K143004VENTURI MiNO TG600/14Talley Group, Ltd.20160—
+3K142626Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set…Medela AG201512—
+3K142979RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft…Smith & Nephew, Inc.2015121
+3K141460Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20154—
+3K143301NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA KitIntegrated Healing Technologies20150—
+3K142956NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome KitIntegrated Healing Technologies20150—
+3K141926Invia Endure Negative Pressure Wound Therapy SystemMedela AG20145—
+3K141033Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG…Argentum Medical, LLC20140—
+3K140049Moves SLCThornhill Research, Inc.20141—
+3K131966Twin Star Extremity Compartment Syndrome Monitor and Fluid Collection Catheter SystemTwin Star Medical, Inc.20147—
+3K123507Kci NPWT Gauze DressingKci USA, Inc.201311—
+3K130210Medela ThopazMedela AG20132—
+3K122132Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large)…Molnlycke Health Care201321—
+3K112853Voltera Powered Suction PumpSuzric Enterprise Co., Ltd.20123—
+3K113678Invia Motion Negative Pressure Wound Therapy SystemMedela AG201211—
+3K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc.201225—
+3K110078ExtricareDevon Medical Products, Inc.20129—
+3K112458Prospera Pro-I, Pro-II and Pro-Iii Negative Pressure Wound Therapy SystemMedica-Rents Co., Ltd.201215—
+3K111170PICOSmith & Nephew, Inc.201126—
+3K112784Renasys AB Abominal Dressing KitSmith & Nephew, Inc.201110—
+3K111333Antlia Iii Wound Treatment SystemInnovative Therapies, Inc.20115—
+3K103042Atmos E 201 Thorax and Atmos S 201 ThoraxAtmos, Inc.20111—
+3K100823Wound Pro ApexAccuro Medical Products, LLC2011101
+3K090258Venturi NPWT V. II Advanced Vacuum SystemTalley Medical20091—
+3K091038AS 1000 Ultrasound Wound Therapy SystemArobella Medical, LLC20090—
+3K090130Atmos S041 WoundAtmos, Inc.20091—
+3K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc.2009562
+3K082676Genadyne A4 Wound Vacuum SystemGenadyne Biotechnologies, Inc.200811—
+3K082211Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc.2008681
+3K082426Renasys EZSmith & Nephew, Inc.2008584
+3K062544AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC200751
+4K241799ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system…Atmos Medizintechnik GmbH & Co. KG20250—
+4K243576RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze…Smith & Nephew Medical, Ltd.20251—
+4K202783Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film DressingSmith & Nephew Medical Limited20220—
+4K193321MY01 Continuous Compartmental Pressure MonitorMY01, Inc.20206—
+4K173916Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20182—
+4K180991AG 100sHospitech Respiration, Ltd.20181—
+4K173407VT - 100, VT - 200Carilex Medical, Inc.20181—
+4K172725VT Dressing KitsCarilex Medical, Inc.20181—
+4K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG20183—
+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—
+4K160967Finapres Nova Noninvasive Hemodynamic MonitorFinapres Medical Systems B.V.20173—
+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
+4K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC20160—
+4K161410VT·One, VT·One 60daysCarilex Medical, Inc.20160—
+4K152163Renasys GOSmith & Nephew, Inc.20160—
+4K162129RENASYS-G Gauze Dressing Kits with Soft PortSmith & Nephew, Inc.20160—
+4K153209RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH…Smith & Nephew Medical, Ltd.20165—
+4K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd.201623—
+4K151872Avance Y-Connector SMolnlycke Health Care Us, LLC20152—
+4K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…Smith & Nephew, Inc.20155—
+4K151326RENASYS¿ EZ PLUS Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.20150—
+4K142385Whisper Pump SystemWound RX Medical, LLC20150—
+4K143016Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at HomeCardinalhealth201542
+4K141847Avance Foam Dressing KitsMolnlycke Health Care Us, LLC201514—
+4K140022Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus NPWT…Cork Medical Products, LLC20145—
+4K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…Devon Medical, Inc.20144—
+4K141553Medela Thopaz+Medela AG20141—
+4K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC20140—
+4K132225ExtricareDevon Medical, Inc.20148—
+4K132004NPWT Wound Dressing Kit- Medium, NPWT Wound Dressing Kit- LargeCreo Quality, LLC20141—
+4K130852Avance® Foam Abdominal Dressing KitMolnlycke Health Care20143—
+4K122490KulavacCG Bio Co., Ltd.20130—