510(k) Report

Devices descending from K961166

42 later devices reach Flowtron Excel Pump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130571Devon Cirona 6100 DVTDevon Medical, Inc.20136—
+1K072372Phlebopress Model 601A Compression Therapy DeviceMego Afek20070—
+1K061125Dvtcare CA5Doctors Orders200630—
+1K012403Vanguard Reprocessed Compression GarmentVanguard Medical Concepts, Inc.200136
+2K151158ALP VasQcare Take Home SystemCurrie Medical Specialties, Inc.20150—
+2K141578Devon Cirona 6200 DVTDevon Medical20144—
+2K133274Vena ProInnovamed Health, LLC201422—
+2K131743Cirona DVT Foot GarmentDevon Medical, Inc.20130—
+2K130174Dvtcare CA5Ossur Americas, Inc.20132—
+2K121376Compression Care FlightMedical Minds, LLC20120—
+2K111748Recovery+ Model PS 511, Dvtherapy Model PS 511AJoy Long20110—
+2K111720AviafitFlowmedic, Ltd.20110—
+2K103187Tripleplay-VT Vascular Therapy SystemWildcat Medical, Inc.201125—
+2K100969Wmi DVT Wrap, Wmi Thermal Wrap Model: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF…Wmi Enterprises, LLC20100—
+2K100909Reprocessed Compression SleevesAscent Healthcare Solutions201001
+2K052691Suretek Medical Reprocessed Compression SleevesSuretek Medical20060—
+2K051438Vanguard Reprocessed Compression Garments (Hill-Rom)Alliance Medical, Inc.200611
+3K241096Venera 608 Deep Vein Thrombosis (DVT) Prevention SystemSuzhou Minhua Medical Apparatus Supplies Co., Ltd.20250—
+3K211253PlasmaWaveManamed, Inc.20210—
+3K203310SyneCare 1000 Deep Vein Thrombosis Prevention Therapy SystemJiangsu Synecoun Medical Technology Co., Ltd.20211—
+3K200285VenaOneVena Group, LLC20201—
+3K193020VenaPro Vascular Therapy SystemInnovamed Health, LLC20192—
+3K190975Plexus SCD110 Sequential Compression Device SleeveMidway Medical, LLC20190—
+3K182578Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy DeviceDevon Medical Products (Jiangsu), Ltd.20190—
+3K180248VascuEase IC-1200-WHBio Compression Systems, Inc.20181—
+3K160318PlasmaFlowManamed, Inc.20164—
+3K151189Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention SystemDevon Medical Products20155—
+3K142728ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx…Medical Compressions System (Dbn), Ltd.20142—
+4K232270DVT Motion Pneumatic Compression DeviceKoge Micro Tech Co., Ltd.20240—
+4K211937SyneCare 1100 Deep Vein Thrombosis Prevention Therapy SystemJiangsu Synecoun Medical Technology Co., Ltd.20210—
+4K212731Circul8 ProOrtho8, Inc.20210—
+4K211235CIRCUL8 Luxe DVT Prevention DeviceOrtho8, Inc.20210—
+4K211200WoundExpressHuntleigh Healthcare, Ltd.20210—
+4K200353ManaFlowManamed, Inc.20201—
+4K200568B&J MHP800 Deep Vein Thrombosis (DVT) Prevention SystemB&J Manufacturing, Ltd.20200—
+4K191107PlexusAlleva Medical (D.G), Ltd.20190—
+4K180389Venera 508 Deep Vein Thrombosis (DVT) Prevention SystemSuzhou Minhua Medical Apparatus Supplies Co., Ltd.20181—
+4K170814Devon 24Devon Medical Products (Jiangsu), Ltd.20170—
+4K151377ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCareMedical Compression System (Dbn), Ltd.20151—
+5K240011Lymphedema CompressionJkh Health Co., Ltd.20240—
+5K183349AeroDVx SystemSun Scientific, Inc.20190—
+5K160431ActiveCare HomeMedical Compression Systems (Dbn), Ltd.20160—