510(k) Report

Devices descending from K000653

27 later devices reach Aeronox Universal, Model P/N 360000, Aeronox Bedside, Model P/N 360001… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093260Aeronox Nitric Oxide Titration & Monitoring SystemInternational Biomedical, Ltd.20091—
+1K061901Ino Therapeutics Inomax DS (Delivery System), Model 10003Ino Therapeutics2006243
+2K193481AeroNOx 2.0 Nitric Oxide Titration & Monitoring SystemInternational Biomedical20200—
+2K131686Inomax Dsir (Delivery System)Ino Therapeutics/Ikaria201354
+2K130605Inomax Dsir (Delivery System)Ino Therapeutics20136—
+2K121021Inomax DS (Delivery System)Ino Therapeutics20127—
+2K120216Genosyl MV-1000Geno, LLC20120—
+2K113272Inomax DS (Delivery SystemsIno Therapeutics, LLC/Dba Ikaria20128—
+2K110344Inomax Dsir (Delivery System)Ino Therapeutics20119—
+2K110635Inomax DS (IR) (Delivery System)Ino Therapeutics, LLC/Dba Ikaria20119—
+2K093922Inomax DSIno Therapeutics2010111
+2K092545Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC201016—
+2K090958Inomax DS (Delivery System)Ino Therapeutics, LLC200911—
+2K081691Inomax DS (Delivery System)Ino Therapeutics, LLC200811—
+2K080484Inomax DS (Delivery System), Model 10003Ino Therapeutics200811—
+2K071516Inomax DSIno Therapeutics, LLC200714—
+2K070867Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC200715—
+3K211153Inomax DSIRMallinckrodt Manufacturing, LLC20230—
+3K200389INOmax DSIR PlusMallinckrodt Manufacturing, LLC20203—
+3K171696NOxBOXi Nitric Oxide Delivery SystemPraxair Distribution, Inc.20184Class I
+3K143213INOmax DSIR Plus MRIIno Therapeutics/Ikaria20150—
+4K212409Ulspira TS Nitric Oxide Therapy SystemAirgas Therapeutics20231—
+4K220898NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.20222Class I
+4K201339The NOxBOXi Nitric Oxide Delivery SystemPraxair, Inc.20203Class I
+5K242374ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLC20250—
+5K231823NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.20231Class I
+6K233251NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc.20240Class I