510(k) Report

Devices descending from K061367

24 later devices reach Bluesky Vista Wound Vacuum System, Model 100.0500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100823Wound Pro ApexAccuro Medical Products, LLC2011101
+1K090130Atmos S041 WoundAtmos, Inc.20091—
+1K082676Genadyne A4 Wound Vacuum SystemGenadyne Biotechnologies, Inc.200811—
+2K150960WoundPro Negative Pressure Wound Therapy SystemPensar Medical, LLC20160—
+2K142385Whisper Pump SystemWound RX Medical, LLC20150—
+2K140022Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus NPWT…Cork Medical Products, LLC20145—
+2K132225ExtricareDevon Medical, Inc.20148—
+2K132004NPWT Wound Dressing Kit- Medium, NPWT Wound Dressing Kit- LargeCreo Quality, LLC20141—
+2K090638Genadyne A4-XLR8 Wound Vacuum SystemGenadyne Biotechnologies, Inc.20092—
+3K243187Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)Cork Medical20251—
+3K241023Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc.20240—
+3K230677Cork Medical VERSA Negative Pressure Wound System (VCMPP-100)Cork Medical20231—
+3K221223extriCARE® 3000 Negative Wound Pressure Therapy SystemAlleva Medical Devices20230—
+3K202898Tzoar 207 Negative Pressure Wound Therapy (NPWT) SystemLightstone Medical Products (Ningbo) Co, Ltd.20210—
+3K203693Nisus Touch Negative Pressure Wound Therapy PumpCork Medical Products, LLC20210—
+3K182458Longterm NPWT Foam Dressing KitZhejiang Longterm Medical Technology Co., Ltd.20190—
+3K143726XLR8 Plus (XLR8+)Genadyne Biotechnologies, Inc.20150—
+3K141437XLR8 Plus (XLR8+)Genadyne Biotechnologies, Inc.20140—
+3K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…Devon Medical, Inc.20144—
+4K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical20260—
+4K241061VERSA Negative Pressure Wound Therapy System (VCMPP-100)Cork Medical20240—
+4K162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC20173—
+5K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam KitZhejiang Longterm Medical Technology Co., Ltd.20220—
+5K202823Innomed NPWT Silicone Foam DressingZhejiang Longterm Medical Technology Co., Ltd.20210—