510(k) Report

Devices descending from K163255

15 later devices reach CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K244007ArteVuCardio Ring Technologies, Inc. Taiwan Branch20250—
+1K211588Caretaker Platform, VitalStream Platform, CT5Caretaker Medical20210—
+1K190792BB-613WPBiobeat Technologies, Ltd.201912—
+2K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+2K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+2K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+2K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+2K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+3K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+3K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+3K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+3K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+3K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+4K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+4K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—