510(k) Report

Devices descending from K032310

112 later devices reach Mini V.a.C., V.a.C. Freedom, V.a.C. Ats through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191760PICO 14 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20192—
+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—
+6K162129RENASYS-G Gauze Dressing Kits with Soft PortSmith & Nephew, Inc.20160—
+6K151326RENASYS¿ EZ PLUS Negative Pressure Wound Therapy DeviceSmith & Nephew, Inc.20150—
+7K260646Renasys Edge (66803126)Smith & Nephew Medical, Ltd.20260—
+7K251826RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologySmith & Nephew Medical, Ltd.20250—
+7K213906extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd.20231—
+7K221891UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20220—
+7K211318PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative…Smith Nephew Medical Limited20220—
+8K251646extriCARE® 1000 Negative Pressure Wound Therapy SystemAlleva Medical Devices20250—