510(k) Report

Devices descending from K993637

715 later devices reach N-395 Pulse Oximeter, with Extended Device Claims through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+10K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—
+10K242518Hypertension Prediction Index (HePI) AlgorithmEdwards Lifesciences, LLC20250—
+10K230842SignalHF (IM008)Implicity, Inc.20230—
+10K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC202362
+10K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…Edwards Lifesciences, LLC20237—
+10K230057Acumen Hypotension Prediction Index (HPI) AlgorithmEdwards Lifesciences, LLC20235—
+10K223651Cerebral Adaptive Index (CAI) AlgorithmEdwards Lifesciences, LLC20236—
+10K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+10K221203AHI SystemFifth Eye, Inc.20220—
+10K212271smart-syncNorthh Medical GmbH20220—
+10K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—
+11K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLC20250—
+11K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+11K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—