510(k) Report

Devices descending from K230497

2 later devices reach Bladder AI (AIBV01) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232257Clarius Bladder AIClarius Mobile Health Corp.20231—
+2K243853Clarius Prostate AIClarius Mobile Health Corp.20250—