510(k) Report

Devices descending from K150893

5 later devices reach IntelliCuff through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243562CuffGuardIdmed20250—
+1K220854TrachCuff Cuff ControllerAw Technologies Aps20231—
+1K221477AG100sHospitech Respiration, Ltd.20220—
+1K202874Puritan Bennett Cuff Pressure ManagerCovidien, LLC202101
+2K261499TrachFlushAw Technologies Aps20260—