510(k) Report

Devices descending from K083861

6 later devices reach Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133012SentieroPath Medical GmbH201444
+1K121847TITANInteracoustics A/S20120—
+2K220139QScreenPath Medical GmbH20220—
+2K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH202204
+2K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.20171—
+3K183201Hearing Healthcare ProDb Diagnostic Systems, Inc.20190—