510(k) Report

Devices descending from K040208

14 later devices reach Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-Band through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+1K101097Calgaeseal Model: CasBz Medical, Inc.20100—
+1K092503Radar Vascular Compression DevicesAdvanced Vascular Dynamics20099—
+1K091194Algiseal PadEvolution Medical Technologies, LLC20091—
+2K181641QuikClot RadialZ-Medica, LLC20180—
+2K142122Radar Vascular Compression DeviceAdvanced Vascular Dynamics20143—
+2K123041Vasostat Hemostasis DeviceForge Medical, Inc.20131—
+2K111837Radial Artery Compression TourniquetLepu Medical Technology (Beijing) Co., Ltd.20114—
+3K153259VasoStat Hemostasis DeviceForge Medical, Inc.20160—
+3K151363Zephyr Vascular Compression DeviceAdvanced Vascular Dynamics20151—
+3K142359Vasc Band hemostatLepu Medical Technology (Beijing) Co., Ltd.20143—
+4K170958ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cmTricol Biomedical, Inc.20170—
+4K162988PreludeSYNC Radial Compression DeviceMerit Medical Systems, Inc.201711
+5K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.20260—