510(k) Report

Devices descending from K041416

2 later devices reach Exac-Temp Foley Catheter and Clini-Temp Foley Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200757Foley Catheter with Temperature SensorDeroyal Industries, Inc.20200—
+1K061918Foley Catheters with Temperature ProbeGE Healthcare20060—