510(k) Report

Devices descending from K042134

159 later devices reach Versatile 1 Wound Vacuum System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K133333Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing KitBlue Ocean Medical Product, LLC20144—
+4K141437XLR8 Plus (XLR8+)Genadyne Biotechnologies, Inc.20140—
+4K132936Novopore DressingPolynovo Biomaterials Pty, Ltd.20140—
+4K123980Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc.20130—
+4K113678Invia Motion Negative Pressure Wound Therapy SystemMedela AG201211—
+4K113199Kevo NPWT-AHEMO30 and a HEMO45 Foam Dressing KitKevo Medical Supplies201210—
+4K111949AC Wound Treatment SystemNanovibronix, Inc.20120—
+4K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc.201225—
+4K111170PICOSmith & Nephew, Inc.201126—
+4K102001Modification to Renasys EZ Plus Negative Pressure Wound TherapySmith & Nephew, Inc.2010143
+5K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical20260—
+5K254019Wound Geni NPWT SystemBechtel Medical, Inc.20260—
+5K241061VERSA Negative Pressure Wound Therapy System (VCMPP-100)Cork Medical20240—
+5K223388Invia® Integrated DressingMedela AG20230—
+5K223332Task Force CORECnsystems Medizintechnik GmbH20230—
+5K221477AG100sHospitech Respiration, Ltd.20220—
+5K223041Renasys Edge (66803126)Smith & Nephew Medical Limited202223
+5K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG20220—
+5K182722XLR8 Abdominal Wound Dressing KitGenadyne Biotechnologies20190—
+5K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC20191—
+5K190228Transcranial Doppler Ultrasound SystemShenzhen Delica Medical Equipment Co., Ltd.20190—
+5K163387PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited201711—
+5K161432MyNeWT Negative Pressure Wound Therapy SystemStortford Medical, LLC20170—
+5K161128Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days…Medela AG201641
+5K161570Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium…Lc Medical Concepts, Inc.20162—
+5K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd.201623—
+5K150459FloSure Ventilation PatchSimex Medizintechnik GmbH20160—
+5K151261Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit…Medela AG20159—
+5K150124Cardinal Health NPWT PRO HCCardinalhealth20153—
+5K141926Invia Endure Negative Pressure Wound Therapy SystemMedela AG20145—
+5K132446Renasys EZ Max Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.201313—
+6K231939Renasys EdgeSmith & Nephew Medical, Ltd.20241—
+6K212359PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC20220—
+6K211277Theia NPWT Foam Wound Dressing KitClear Choice Therapeutics, Inc.20211—
+6K203369Avance Solo Negative Pressure Wound Therapy (NPWT) SystemMolnlycke Health Care Us, LLC20210—
+6K200223PocketDoc™ Micro Wound Therapy SystemPensar Medical, LLC20200—
+6K180840UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20183—
+6K180205AVELLE Negative Pressure Wound Therapy SystemConvatec Limited20183—
+6K180698PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20186—
+6K172005PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20188—
+6K171499Occlusion Detection Dressing KitCardinalhealth20170—
+6K172521PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20171—
+6K172519PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20170—
+6K161599UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20174—
+6K161418Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery SetCardinalhealth20171—
+7K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.20260—
+7K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building20260—
+7K260646Renasys Edge (66803126)Smith & Nephew Medical, Ltd.20260—
+7K232379PREVENT KitClear Choice Therapeutics20240—
+7K202157PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative…Smith & Nephew Medical Limited20201—
+7K190028UNO 30Genadyne Biotechnologies20201—
+7K191760PICO 14 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20192—
+7K181929MiMo (TM) Negative Pressure Wound Therapy SystemBaymax Research, Inc.20190—
+7K182323PICO 7Y Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20190—
+7K180614PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20180—
+8K213906extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd.20231—
+8K221891UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20220—
+8K211318PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative…Smith Nephew Medical Limited20220—
+9K251646extriCARE® 1000 Negative Pressure Wound Therapy SystemAlleva Medical Devices20250—