510(k) Report

Devices descending from K143185

4 later devices reach entré Model PD08-U through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254217AerloomEvolym, LLC20260—
+1K234155Nimbl (model PD08-N1)Tactile Medical20240—
+1K212287Dayspring LiteKoya Medical, Inc.20210—
+1K200564Aria SystemInova Labs20200—