510(k) Report

Devices descending from K014063

106 later devices reach Task Force Monitor 3040 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K260008Deterioration Index Version 2Epic Systems Corporation20260—
+11K251326Respiration Rate algorithmEdwards Lifesciences, LLC20260—
+11K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences20240—
+11K233984Acumen Assisted Fluid Management (AFM) Software FeatureEdwards Lifesciences, LLC20240—
+11K230612Edwards Algorithm for Measurement of Blood HemoglobinEdwards Lifesciences, LLC20235—
+11K221203AHI SystemFifth Eye, Inc.20220—