510(k) Report

Devices descending from K003665

28 later devices reach Fadassi Medical FM-1 NO Blender through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052663Ino Therapeutics Inoblender, Model 10004Ino Therapeutics200526—
+1K011874Fadasis Medical FM-1 NO BlenderFadasis Medical, Inc.200127—
+2K122689InoblenderIno Therapeutics20125—
+2K061901Ino Therapeutics Inomax DS (Delivery System), Model 10003Ino Therapeutics2006243
+3K171696NOxBOXi Nitric Oxide Delivery SystemPraxair Distribution, Inc.20184Class I
+3K131686Inomax Dsir (Delivery System)Ino Therapeutics/Ikaria201354
+3K130605Inomax Dsir (Delivery System)Ino Therapeutics20136—
+3K121021Inomax DS (Delivery System)Ino Therapeutics20127—
+3K120216Genosyl MV-1000Geno, LLC20120—
+3K113272Inomax DS (Delivery SystemsIno Therapeutics, LLC/Dba Ikaria20128—
+3K110344Inomax Dsir (Delivery System)Ino Therapeutics20119—
+3K110635Inomax DS (IR) (Delivery System)Ino Therapeutics, LLC/Dba Ikaria20119—
+3K093922Inomax DSIno Therapeutics2010111
+3K092545Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC201016—
+3K090958Inomax DS (Delivery System)Ino Therapeutics, LLC200911—
+3K081691Inomax DS (Delivery System)Ino Therapeutics, LLC200811—
+3K080484Inomax DS (Delivery System), Model 10003Ino Therapeutics200811—
+3K071516Inomax DSIno Therapeutics, LLC200714—
+3K070867Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC200715—
+4K211153Inomax DSIRMallinckrodt Manufacturing, LLC20230—
+4K220898NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.20222Class I
+4K201339The NOxBOXi Nitric Oxide Delivery SystemPraxair, Inc.20203Class I
+4K200389INOmax DSIR PlusMallinckrodt Manufacturing, LLC20203—
+4K143213INOmax DSIR Plus MRIIno Therapeutics/Ikaria20150—
+5K231823NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.20231Class I
+5K212409Ulspira TS Nitric Oxide Therapy SystemAirgas Therapeutics20231—
+6K242374ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLC20250—
+6K233251NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.20240Class I