510(k) Report

Devices descending from K983552

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K113236Foryou NPWT DeviceForyou Medical Electronics Co, Ltd.20130—
+4K111949AC Wound Treatment SystemNanovibronix, Inc.20120—
+4K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc.20112—
+4K092992A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc.201031—
+4K091470Ranasys EZ Negative Pressure Wound Therapy System, Model 66800059Smith & Nephew, Inc.2009151
+4K090638Genadyne A4-XLR8 Wound Vacuum SystemGenadyne Biotechnologies, Inc.20092—
+4K072904Sonoca 180/195 Wound Care SystemSoering GmbH20081—
+5K254019Wound Geni NPWT SystemBechtel Medical, Inc.20260—
+5K251826RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologySmith & Nephew Medical, Ltd.20250—
+5K243187Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)Cork Medical20251—
+5K241023Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc.20240—
+5K231646Carilex VT¿200-i NXCarilex Medical, Inc.20240—
+5K230677Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)Cork Medical20231—
+5K223388Invia® Integrated DressingMedela AG20230—
+5K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+5K221223extriCARE® 3000 Negative Wound Pressure Therapy SystemAlleva Medical Devices20230—
+5K221477AG100sHospitech Respiration, Ltd.20220—
+5K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG20220—
+5K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitZhejiang Longterm Medical Technology Co., Ltd.20220—
+5K202898Tzoar 207 Negative Pressure Wound Therapy (NPWT) SystemLightstone Medical Products (Ningbo) Co, Ltd.20210—
+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—
+5K202635MY01 Continuous Compartmental Pressure MonitorMY01, Inc.20205—
+5K200223PocketDoc™ Micro Wound Therapy SystemPensar Medical, LLC20200—
+5K190119Foryou NPWT Dressing Kit4l Health Co., Ltd.20190—
+5K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+5K182458Longterm NPWT Foam Dressing KitZhejiang Longterm Medical Technology Co., Ltd.20190—
+5K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited20193—
+5K182191Invia Abdominal Dressing KitMedela AG20190—
+5K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC20192—
+5K181204RENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical Limited20190—
+5K180840UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20183—
+5K181667Thoraguard SystemCentese, Inc.20180—
+5K180415Invia White Foam NPWTMedela AG20180—
+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—
+5K161599UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20174—
+5K161939Avance Abdominal Dressing KitMolnlycke Health Care Us, LLC20161—
+5K161935Avance Foam Dressing Kit - XLMolnlycke Health Care Us, LLC20160—
+5K152741Mepiseal Soft Silicone SealantMolnlycke Health Care Us, LLC20160—
+5K150124Cardinal Health NPWT PRO HCCardinalhealth20153—
+5K143726XLR8 Plus (XLR8+)Genadyne Biotechnologies, Inc.20150—
+5K142646XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit andGenadyne Biotechnologies, Inc.20151—
+5K141961Genadyne Spiro Foam Dressing KitGenadyne Biotechnologies, Inc.20150—
+5K133333Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing KitBlue Ocean Medical Product, LLC20144—
+5K141437XLR8 Plus (XLR8+)Genadyne Biotechnologies, Inc.20140—
+5K132936Novopore DressingPolynovo Biomaterials Pty, Ltd.20140—
+5K123980Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc.20130—
+5K113199Kevo NPWT-AHEMO30 and a HEMO45 Foam Dressing KitKevo Medical Supplies201210—
+5K102001Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc.2010143
+6K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building20260—
+6K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical20260—
+6K241061VERSA Negative Pressure Wound Therapy System (VCMPP-100)Cork Medical20240—
+6K223041Renasys Edge (66803126)Smith & Nephew Medical Limited202223
+6K212359PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC20220—
+6K210525MY01 Continuous Compartmental Pressure MonitorMY01, Inc.202141
+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—
+6K182722XLR8 Abdominal Wound Dressing KitGenadyne Biotechnologies20190—
+6K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC20191—
+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—
+6K171499Occlusion Detection Dressing KitCardinalhealth20170—
+6K161418Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery SetCardinalhealth20171—
+6K161570Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium…Lc Medical Concepts, Inc.20162—
+6K150459FloSure Ventilation PatchSimex Medizintechnik GmbH20160—
+6K151261Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit…Medela AG20159—
+6K132446Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.201313—
+7K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.20260—
+7K231939Renasys EdgeSmith & Nephew Medical, Ltd.20241—
+7K223509Compremium Compartment Compressibility Monitoring System (CPM#1)Compremium AG20230—
+7K213906extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd.20231—
+7K221891UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20220—
+7K220952MY01 Continuous Compartmental Pressure MonitorMY01, Inc.20222—
+7K211318PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative…Smith Nephew Medical Limited20220—
+7K211277Theia NPWT Foam Wound Dressing KitClear Choice Therapeutics, Inc.20211—
+8K260646Renasys Edge (66803126)Smith & Nephew Medical, Ltd.20260—
+8K251646extriCARE® 1000 Negative Pressure Wound Therapy SystemAlleva Medical Devices20250—
+8K242997MY01 Continuous Compartmental Pressure MonitorMY01, Inc.20251—
+8K232379PREVENT KitClear Choice Therapeutics20240—
+9K251900MY01 Continuous Compartmental Pressure MonitorMY01, Inc.20260—