510(k) Report

Devices descending from K100446

22 later devices reach Circuflow 5100 Sequential Compression Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123959Circuflow 5150Devon Medical, Inc.20136—
+1K123647Circuflow 5208 Sequential Compression DeviceDevon Medical, Inc.201312—
+1K101523Circuflow 5200 Sequential Compression DeviceDevon Medical, Inc.201021—
+2K250817Coretech Compression System (Coretech RHB3003)Vive Health, LLC20250—
+2K183631medi pneumatic compression system (pcs) – brio (Model 651)Medi USA, LP20193—
+2K172779AIROS 8 Sequential Compression DeviceAiros Medical, Inc.20182—
+2K172770AIROS 6 Sequential Compression DeviceAiros Medical, Inc.20183—
+2K172030Devon 51Devon Medical Products (Jiangsu), Ltd.20170—
+2K143185entré Model PD08-UTactile Systems Technology, Inc.20154—
+2K102582Arterioflow Model 7500 Sequential Compression DeviceDevon Medical, Inc.20100—
+3K254217AerloomEvolym, LLC20260—
+3K234155Nimbl (model PD08-N1)Tactile Medical20240—
+3K221654medi pneumatic compression system (pcs)-genius (Model 652)Medi USA, LP20220—
+3K212287Dayspring LiteKoya Medical, Inc.20210—
+3K200353ManaFlowManamed, Inc.20201—
+3K200564Aria SystemInova Labs20200—
+3K193069AIROS 6 Sequential Compression DeviceAiros Medical, Inc.20192—
+3K193068AIROS 8 Sequential Compression DeviceAiros Medical, Inc.20191—
+4K240011Lymphedema CompressionJkh Health Co., Ltd.20240—
+4K223193AIROS 8P Sequential Compression DeviceAiros Medical, Inc.20220—
+4K223195AIROS 6P Sequential Compression DeviceAiros Medical, Inc.20221—
+5K251086PnueAira (PNCU-01)Biotab, LLC20250—