510(k) Report

Devices descending from K080484

11 later devices reach Inomax DS (Delivery System), Model 10003 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131686Inomax Dsir (Delivery System)Ino Therapeutics/Ikaria201354
+1K130605Inomax Dsir (Delivery System)Ino Therapeutics20136—
+1K121021Inomax DS (Delivery System)Ino Therapeutics20127—
+1K113272Inomax DS (Delivery SystemsIno Therapeutics, LLC/Dba Ikaria20128—
+1K110344Inomax Dsir (Delivery System)Ino Therapeutics20119—
+1K110635Inomax DS (IR) (Delivery System)Ino Therapeutics, LLC/Dba Ikaria20119—
+2K211153Inomax DSIRMallinckrodt Manufacturing, LLC20230—
+2K200389INOmax DSIR PlusMallinckrodt Manufacturing, LLC20203—
+2K143213INOmax DSIR Plus MRIIno Therapeutics/Ikaria20150—
+3K212409Ulspira TS Nitric Oxide Therapy SystemAirgas Therapeutics20231—
+4K242374ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLC20250—