510(k) Report

Devices descending from K954140

16 later devices reach Masterscreen Ios through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111053Sentrysuite Product LineCarefusion Germany 234 GmbH201111—
+1K101873Masterscreen IosCarefusion Germany 234 GmbH20113—
+2K152585Resmon PRO FULLMedical Graphics Corp.20162—
+2K122699Sentrysuite Product LineCarefusion Germany 234 GmbH20129—
+2K113813Sentrysuite Product LineCarefusion Germany 234 GmbH20120—
+3K190853Vyntus BODYVyaire Medical, Inc.20190—
+3K170185tremoFlo C-100 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc.20171—
+3K153654Sentry WEB SmartInterpCarefusion Germany 234 GmbH20160—
+3K133925Vyntus/ Sentrysuite Product LineCarefusion Germany 234 GmbH20148—
+4K242809Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation20241—
+4K221024tremoflo C2 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc.20230—
+4K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH20155Class I
+5K260242CPETWise PlatformMedibyt, Ltd.20260—
+5K183567Vyntus/SentrySuite Product LineVyaire Medical20190—
+5K183369COR12 EcgCorscience GmbH & Co.20180—
+5K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…Vyaire Medical, Inc.20181—