510(k) Report

Devices descending from K133925

8 later devices reach Vyntus/ Sentrysuite Product Line through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242809Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics Corporation20241—
+1K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH20155Class I
+2K260242CPETWise PlatformMedibyt, Ltd.20260—
+2K183567Vyntus/SentrySuite Product LineVyaire Medical20190—
+2K183369COR12 EcgCorscience GmbH & Co.20180—
+2K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…Vyaire Medical, Inc.20181—
+2K153654Sentry WEB SmartInterpCarefusion Germany 234 GmbH20160—
+3K190853Vyntus BODYVyaire Medical, Inc.20190—