510(k) Report

Devices descending from K111170

26 later devices reach PICO through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc.201225—
+2K163387PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited201711—
+2K161432MyNeWT Negative Pressure Wound Therapy SystemStortford Medical, LLC20170—
+2K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd.201623—
+3K202823Innomed NPWT Silicone Foam DressingZhejiang Longterm Medical Technology Co., Ltd.20210—
+3K203369Avance Solo Negative Pressure Wound Therapy (NPWT) SystemMolnlycke Health Care Us, LLC20210—
+3K200223PocketDoc™ Micro Wound Therapy SystemPensar Medical, LLC20200—
+3K180840UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20183—
+3K180205AVELLE Negative Pressure Wound Therapy SystemConvatec Limited20183—
+3K180698PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20186—
+3K172005PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20188—
+3K172521PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20171—
+3K172519PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20170—
+3K161599UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20174—
+4K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building20260—
+4K212359PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC20220—
+4K202157PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative…Smith & Nephew Medical Limited20201—
+4K190028UNO 30Genadyne Biotechnologies20201—
+4K191760PICO 14 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20192—
+4K181929MiMo (TM) Negative Pressure Wound Therapy SystemBaymax Research, Inc.20190—
+4K182323PICO 7Y Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20190—
+4K180614PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited20180—
+5K213906extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd.20231—
+5K221891UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc.20220—
+5K211318PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative…Smith Nephew Medical Limited20220—
+6K251646extriCARE® 1000 Negative Pressure Wound Therapy SystemAlleva Medical Devices20250—