510(k) Report

Devices descending from K060315

19 later devices reach Healthstats Bpro Ambulatory Blood Pressure Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173028BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC SoftwareHealthstats International Pte., Ltd.201813—
+1K131916Bprosoft Casp PC SoftwareHealthstats International Pte., Ltd.20140—
+1K101002A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200Healthstats International Pte., Ltd.20102—
+1K072593A-Plus Arterial Pulse Waveform Analysis System and PC SoftwareHealthstats International Pte., Ltd.20074—
+2K190792BB-613WPBiobeat Technologies, Ltd.201912—
+2K131788Healthstats a-Pulse Caspal + and MC3100+ Monitors and MY-BP BP Management Application…Healthstats International Pte., Ltd.20140—
+2K121266CardioscopePulsecor Limited20120—
+3K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+3K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+3K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+3K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+3K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+4K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+4K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+4K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+4K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+4K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+5K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+5K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—