510(k) Report

Devices descending from K200389

3 later devices reach INOmax DSIR Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212409Ulspira TS Nitric Oxide Therapy SystemAirgas Therapeutics20231—
+1K211153Inomax DSIRMallinckrodt Manufacturing, LLC20230—
+2K242374ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLC20250—