510(k) Report

Devices descending from K033378

108 later devices reach Vital Signs Monitor, Propaq LT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K252981EmbraceMiniEmpatica S.r.l.20251—
+8K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+8K250757Radius VSM and AccessoriesMasimo Corporation20250—
+8K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+8K232915EpiMonitorEmpatica S.r.l.20241—
+8K231531Pediarity™Hinlab, Inc.20230—
+8K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—
+9K250515EpiMonitorEmpatica S.r.l.20250—