510(k) Report

Devices descending from K071047

7 later devices reach Masimo Patient Safety Net through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110521Everon Central Display Station (CDS)Earlysense, Ltd.20116—
+2K121885Earlysense Central Display SystemEarlysense, Ltd.20125—
+3K151006EarlySense Central Display Station (CDS)Earlysense, Ltd.20154—
+4K212622Zyter RPMZyter, Inc.20220—
+4K202497Aulisa Multiple Patient Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20202—
+5K242842ANNE View, Central HubSibel Health, Inc.20251—
+6K243837iBSMIorbit Digital Technologies Private Limited20250—