510(k) Report

Devices descending from K092992

31 later devices reach A4-XLR8 Foam Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142646XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit andGenadyne Biotechnologies, Inc.20151—
+1K141961Genadyne Spiro Foam Dressing KitGenadyne Biotechnologies, Inc.20150—
+1K133333Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing KitBlue Ocean Medical Product, LLC20144—
+1K140022Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus NPWT…Cork Medical Products, LLC20145—
+1K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…Devon Medical, Inc.20144—
+1K132004NPWT Wound Dressing Kit- Medium, NPWT Wound Dressing Kit- LargeCreo Quality, LLC20141—
+1K132936Novopore DressingPolynovo Biomaterials Pty, Ltd.20140—
+1K113199Kevo NPWT-AHEMO30 and a HEMO45 Foam Dressing KitKevo Medical Supplies201210—
+2K243187Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)Cork Medical20251—
+2K230677Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)Cork Medical20231—
+2K203693Nisus Touch Negative Pressure Wound Therapy PumpCork Medical Products, LLC20210—
+2K182458Longterm NPWT Foam Dressing KitZhejiang Longterm Medical Technology Co., Ltd.20190—
+2K180415Invia White Foam NPWTMedela AG20180—
+2K162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC20173—
+2K161570Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium…Lc Medical Concepts, Inc.20162—
+2K150459FloSure Ventilation PatchSimex Medizintechnik GmbH20160—
+2K151261Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit…Medela AG20159—
+3K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical20260—
+3K241061VERSA Negative Pressure Wound Therapy System (VCMPP-100)Cork Medical20240—
+3K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitZhejiang Longterm Medical Technology Co., Ltd.20220—
+3K211277Theia NPWT Foam Wound Dressing KitClear Choice Therapeutics, Inc.20211—
+3K202823Innomed NPWT Silicone Foam DressingZhejiang Longterm Medical Technology Co., Ltd.20210—
+3K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Medela AG201781
+4K232379PREVENT KitClear Choice Therapeutics20240—
+4K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC20192—
+4K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG20183—
+5K254019Wound Geni NPWT SystemBechtel Medical, Inc.20260—
+5K223388Invia® Integrated DressingMedela AG20230—
+5K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG20220—
+5K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC20191—
+6K212359PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC20220—