510(k) Report

Devices descending from K222930

2 later devices reach Evolve Nitric Oxide Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240410EVOLVE Nitric Oxide Delivery SystemMalinckrodt Manufacturing, LLC20241—
+2K242578EVOLVE Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLC20250—