510(k) Report

Devices descending from K951246

430 later devices reach Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K223578T3 Platform softwareEtiometry, Inc.20232—
+8K223498Radius VSM and AccessoriesMasimo Corporation202312
+8K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+8K213423T3 Platform softwareEtiometry, Inc.20232—
+8K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+8K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+8K222463EchoGo Heart FailureUltromics Limited20227—
+8K220351Polso WatchChronisense Medical, Ltd.20220—
+8K212271smart-syncNorthh Medical GmbH20220—
+8K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+8K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+8K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D…Vitalconnect, Inc.20201—
+8K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+8K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+8K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+9K253186HemoSphere Nano Monitor (HSNANO1)Edwards Lifesciences, LLC20260—
+9K251293CardioVisionIcardio.Ai20250—
+9K253034HemoSphere Stream ModuleEdwards Lifesciences20250—
+9K250757Radius VSM and AccessoriesMasimo Corporation20250—
+9K241479Etiometry Platform (DAV 5.4 RAE 9.2)Etiometry, Inc.20251—
+9K240860EchoGo Amyloidosis (1.0)Ultromics Limited20242—
+9K240013EchoGo Heart Failure (2.0)Ultromics Limited20240—
+9K231531Pediarity™Hinlab, Inc.20230—
+9K223905Vivio® LVEDP SystemAvicena, LLC20230—
+9K231335Cleerly ISCHEMIACleerly, Inc.20230—
+9K231276SmartCardia 7L PlatformSmartcardia SA20230—
+9K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—
+10K254066Etiometry PlatformEtiometry, Inc.20260—
+10K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+10K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—