510(k) Report

Devices descending from K050896

10 later devices reach H12+ Holter Recorder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151787Holter SystemEdan Instruments, Inc.20162—
+1K091505COR12+Viasys Healthcare GmbH20096—
+2K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd.20260—
+2K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc.20260—
+2K150810Vyntus / SentrySuite Product LineCarefusion Germany 234 GmbH20155Class I
+3K183567Vyntus/SentrySuite Product LineVyaire Medical20190—
+3K183369COR12 EcgCorscience GmbH & Co.20180—
+3K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…Vyaire Medical, Inc.20181—
+3K153654Sentry WEB SmartInterpCarefusion Germany 234 GmbH20160—
+4K190853Vyntus BODYVyaire Medical, Inc.20190—