510(k) Report

Devices descending from K142476

6 later devices reach Master Caution Device MCD through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173248CardioskinBioserenity Sas20180—
+1K161431SimplECGNanowear, Inc.20165—
+2K201669SimpleSENSENanowear, Inc.20203—
+3K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+3K212160SimpleSENSE PlatformNanowear, Inc.20211—
+4K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—