510(k) Report

Devices descending from K021681

113 later devices reach Micropaq, Models 402, 404 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+8K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+8K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+8K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+9K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+9K252981EmbraceMiniEmpatica S.r.l.20251—
+9K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+9K250757Radius VSM and AccessoriesMasimo Corporation20250—
+9K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+9K232915EpiMonitorEmpatica S.r.l.20241—
+9K231531Pediarity™Hinlab, Inc.20230—
+9K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—
+10K250515EpiMonitorEmpatica S.r.l.20250—