Atlas FDA

MRN

33 FDA 510(k) clearances · Product code

120 daysmedian time to decision
436 days90th percentile
33clearances measured

FDA profile

Official device name
Apparatus, Nitric Oxide Delivery
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5165
Medical specialty
Anesthesiology
Flags
Life-sustaining
Adverse events (MAUDE)
2021: 221 · 2022: 115 · 2023: 99 · 2024: 138 · 2025: 158 · 2026: 96
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ULSPIRA TS™ Nitric Oxide Therapy System (K242374)Airgas Therapeutics, LLC2025-01-17
EVOLVE Nitric Oxide Delivery System (K242578)Mallinckrodt Manufacturing, LLC2025-01-03
EVOLVE Nitric Oxide Delivery System (K240410)Malinckrodt Manufacturing, LLC2024-05-28
NOxBOXi Nitric Oxide Delivery System (K233251)Linde Gas & Equipment, Inc.2024-05-23
Evolve Nitric Oxide Delivery System (K222930)Mallinckrodt Manufacturing, LLC2023-12-06
NOxBOXi Nitric Oxide Delivery System (K231823)Linde Gas & Equipment, Inc.2023-08-11
Ulspira TS Nitric Oxide Therapy System (K212409)Airgas Therapeutics2023-06-30
Inomax DSIR (K211153)Mallinckrodt Manufacturing, LLC2023-04-20
NOxBOXi Nitric Oxide Delivery System (K220898)Linde Gas & Equipment, Inc.2022-04-27
The NOxBOXi Nitric Oxide Delivery System (K201339)Praxair, Inc.2020-06-19
INOmax DSIR Plus (K200389)Mallinckrodt Manufacturing, LLC2020-06-17
AeroNOx 2.0 Nitric Oxide Titration & Monitoring System (K193481)International Biomedical2020-03-10
NOxBOXi Nitric Oxide Delivery System (K171696)Praxair Distribution, Inc.2018-10-02
INOmax DSIR Plus MRI (K143213)Ino Therapeutics/Ikaria2015-07-10
INOMAX DSIR (DELIVERY SYSTEM) (K131686)Ino Therapeutics/Ikaria2013-11-29
INOMAX DSIR (DELIVERY SYSTEM) (K130605)Ino Therapeutics2013-05-02
INOMAX DS (DELIVERY SYSTEM) (K121021)Ino Therapeutics2012-09-24
GENOSYL MV-1000 (K120216)Geno, LLC2012-05-16
INOMAX DS(DELIVERY SYSTEMS (K113272)Ino Therapeutics, LLC/Dba Ikaria2012-02-29
INOMAX DSIR (DELIVERY SYSTEM) (K110344)Ino Therapeutics2011-06-24
INOMAX DS(IR) (DELIVERY SYSTEM) (K110635)Ino Therapeutics, LLC/Dba Ikaria2011-06-23
INOMAX DS (K093922)Ino Therapeutics2010-04-15
INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (K092545)Ino Therapeutics, LLC2010-03-10
AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM (K093260)International Biomedical, Ltd.2009-12-16
INOMAX DS (DELIVERY SYSTEM) (K081691)Ino Therapeutics, LLC2008-08-28
INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (K080484)Ino Therapeutics2008-08-06
INOMAX DS (K071516)Ino Therapeutics, LLC2007-10-03
INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (K070867)Ino Therapeutics, LLC2007-04-27
INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (K061901)Ino Therapeutics2006-12-14
VIANOX DELIVERY SYSTEM, MODEL II (K033779)Pulmonox Medical, Inc.2004-01-26
AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002 (K000653)Pulmonox Medical Corp.2000-08-04
DATEX-OHMEDA INOVENT DELIVERY SYSTEM (K000186)Datex-Ohmeda2000-02-10
OHMEDA INOVENT DELIVERY SYSTEM (DEN000001)Ohmeda Medical2000-01-11

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Every clearance here is in the API, with alerts when new ones post.