510(k) Report

Devices descending from K131686

5 later devices reach Inomax Dsir (Delivery System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211153Inomax DSIRMallinckrodt Manufacturing, LLC20230—
+1K200389INOmax DSIR PlusMallinckrodt Manufacturing, LLC20203—
+1K143213INOmax DSIR Plus MRIIno Therapeutics/Ikaria20150—
+2K212409Ulspira TS Nitric Oxide Therapy SystemAirgas Therapeutics20231—
+3K242374ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLC20250—