510(k) · Cleared
ClearedInomax DSIR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mallinckrodt Manufacturing, LLC · MRN Apparatus, Nitric Oxide Delivery
Cleared on Apr 20, 2023 as substantially equivalent to K200389 (Mallinckrodt Manufacturing, LLC, 2020) and 1 other predicate after a 731-day review. Its family tree reaches back 13 generations to 2001.
- Decided
- Apr 20, 2023
- Review
- 731 days
- Class
- Class II
- Product code
- MRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K003665 (2001). 21 ancestors in all, the oldest K000186 (2000). No later device cites it as a predicate yet.
- Root · 13 generations backK003665 Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
- 9 generations between
- 3 generations backK130605 Inomax Dsir (Delivery System)Ino Therapeutics · 2013
- 2 generations backK131686 Inomax Dsir (Delivery System)Ino Therapeutics/Ikaria · 2013 · Recalled
- 1 generation backK200389 INOmax DSIR PlusMallinckrodt Manufacturing, LLC · 2020
- This deviceK211153 Inomax DSIRMallinckrodt Manufacturing, LLC · 2023
Show all 13 generations
- Root · 13 generations backK003665 Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
- 12 generations backK011874 Fadasis Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
- 11 generations backK052663 Ino Therapeutics Inoblender, Model 10004Ino Therapeutics · 2005
- 10 generations backK061901 Ino Therapeutics Inomax DS (Delivery System), Model 10003Ino Therapeutics · 2006 · Recalled
- 9 generations backK070867 Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC · 2007
- 8 generations backK071516 Inomax DSIno Therapeutics, LLC · 2007
- 7 generations backK080484 Inomax DS (Delivery System), Model 10003Ino Therapeutics · 2008
- 6 generations backK110635 Inomax DS (IR) (Delivery System)Ino Therapeutics, LLC/Dba Ikaria · 2011
- 5 generations backK113272 Inomax DS (Delivery SystemsIno Therapeutics, LLC/Dba Ikaria · 2012
- 4 generations backK121021 Inomax DS (Delivery System)Ino Therapeutics · 2012
- 3 generations backK130605 Inomax Dsir (Delivery System)Ino Therapeutics · 2013
- 2 generations backK131686 Inomax Dsir (Delivery System)Ino Therapeutics/Ikaria · 2013 · Recalled
- 1 generation backK200389 INOmax DSIR PlusMallinckrodt Manufacturing, LLC · 2020
- This deviceK211153 Inomax DSIRMallinckrodt Manufacturing, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K003665 | Fadassi Medical FM-1 NO Blender | Fadasis Medical, Inc. | 2001 | — |
| −12 | K011874 | Fadasis Medical FM-1 NO Blender | Fadasis Medical, Inc. | 2001 | — |
| −11 | K052663 | Ino Therapeutics Inoblender, Model 10004 | Ino Therapeutics | 2005 | — |
| −10 | K061901 | Ino Therapeutics Inomax DS (Delivery System), Model 10003 | Ino Therapeutics | 2006 | 3 |
| −9 | K070867 | Inomax DS (Delivery System), Model 10003 | Ino Therapeutics, LLC | 2007 | — |
| −8 | K071516 | Inomax DS | Ino Therapeutics, LLC | 2007 | — |
| −7 | K080484 | Inomax DS (Delivery System), Model 10003 | Ino Therapeutics | 2008 | — |
| −6 | K110635 | Inomax DS (IR) (Delivery System) | Ino Therapeutics, LLC/Dba Ikaria | 2011 | — |
| −5 | K113272 | Inomax DS (Delivery Systems | Ino Therapeutics, LLC/Dba Ikaria | 2012 | — |
| −4 | K121021 | Inomax DS (Delivery System) | Ino Therapeutics | 2012 | — |
| −3 | K130605 | Inomax Dsir (Delivery System) | Ino Therapeutics | 2013 | — |
| −2 | K131686 | Inomax Dsir (Delivery System) | Ino Therapeutics/Ikaria | 2013 | 4 |
| −1 | K200389 | INOmax DSIR Plus | Mallinckrodt Manufacturing, LLC | 2020 | — |
| 0 (this device) | K211153 | Inomax DSIR | Mallinckrodt Manufacturing, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MRN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MRN device
- #1 K242374 ULSPIRA TS™ Nitric Oxide Therapy Systemscore 12.6 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K200389 | INOmax DSIR PlusSummary page 4…kup Delivery Device Classification: Class II – 21 CFR 868.5165 Product Code: MRN (Primary), MRQ, MRP Predicate Device(s) K200389 Description of Device The INOmax DSIR® Plus uses a "dual-channel" design to ensure the safe delivery… | 2020 |
| * | K131686 | Inomax Dsir (Delivery System)Summary page 6…table below. Comparison to Predicate Device Feature / INOmax DSIR® Plus- INOmax DSIR® Plus Device Modification Specification K131686 DSIR Head DSIR Head Modified DSIR head with RoHS compliant… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 8 months on median.
- 4 of the 21 ancestors have a recall of any class.
- 1 other device also cites its predicate K200389.
How does its category compare?
All MRN devicesMRN Apparatus, Nitric Oxide Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MRN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRN
566in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRN
2in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · MRN
155in 2025
MAUDE reports naming product code MRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 9 |
| 2009 | 1 | — | 0 | 10 |
| 2010 | 2 | — | 2 | 155 |
| 2011 | 2 | — | 0 | 55 |
| 2012 | 3 | 117 | 0 | 24 |
| 2013 | 2 | — | 0 | 32 |
| 2014 | 0 | — | 1 | 79 |
| 2015 | 1 | — | 0 | 156 |
| 2016 | 0 | — | 0 | 94 |
| 2017 | 0 | — | 0 | 106 |
| 2018 | 1 | — | 0 | 138 |
| 2019 | 0 | — | 0 | 144 |
| 2020 | 3 | 84 | 0 | 199 |
| 2021 | 0 | — | 0 | 221 |
| 2022 | 1 | — | 0 | 115 |
| 2023 | 4 | 566 | 1 | 99 |
| 2024 | 2 | — | 0 | 138 |
| 2025 | 2 | — | 2 (2) | 155 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The INOmax® DSIR Plus delivery system delivers INOMAX® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It…
Read the full statement (271 words)
The INOmax® DSIR Plus delivery system delivers INOMAX® (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with ventilators and respiratory care devices that the INOmax DSIR Plus has been validated with.
The INOmax® DSIR Plus provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.
The INOmax® DSIR Plus incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.
The INOmax® DSIR Plus includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the INOblender® for backup.
The INOmax® DSIR Plus must only be used in accordance with the indications, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. INOmax DSIR Plus is indicated for a maximum of 14 days of use. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211153: Inomax DSIR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211153
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026