510(k) · Cleared
ClearedINOmax DSIR Plus MRI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ino Therapeutics/Ikaria · MRN Apparatus, Nitric Oxide Delivery
Cleared on Jul 10, 2015 as substantially equivalent to K131686 (Ino Therapeutics/Ikaria, 2013) after a 242-day review. Its family tree reaches back 12 generations to 2001.
- Decided
- Jul 10, 2015
- Review
- 242 days
- Class
- Class II
- Product code
- MRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K003665 (2001). 20 ancestors in all, the oldest K000186 (2000). No later device cites it as a predicate yet.
- Root · 12 generations backK003665 Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
- 8 generations between
- 3 generations backK121021 Inomax DS (Delivery System)Ino Therapeutics · 2012
- 2 generations backK130605 Inomax Dsir (Delivery System)Ino Therapeutics · 2013
- 1 generation backK131686 Inomax Dsir (Delivery System)Ino Therapeutics/Ikaria · 2013 · Recalled
- This deviceK143213 INOmax DSIR Plus MRIIno Therapeutics/Ikaria · 2015
Show all 12 generations
- Root · 12 generations backK003665 Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
- 11 generations backK011874 Fadasis Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
- 10 generations backK052663 Ino Therapeutics Inoblender, Model 10004Ino Therapeutics · 2005
- 9 generations backK061901 Ino Therapeutics Inomax DS (Delivery System), Model 10003Ino Therapeutics · 2006 · Recalled
- 8 generations backK070867 Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC · 2007
- 7 generations backK071516 Inomax DSIno Therapeutics, LLC · 2007
- 6 generations backK080484 Inomax DS (Delivery System), Model 10003Ino Therapeutics · 2008
- 5 generations backK110635 Inomax DS (IR) (Delivery System)Ino Therapeutics, LLC/Dba Ikaria · 2011
- 4 generations backK113272 Inomax DS (Delivery SystemsIno Therapeutics, LLC/Dba Ikaria · 2012
- 3 generations backK121021 Inomax DS (Delivery System)Ino Therapeutics · 2012
- 2 generations backK130605 Inomax Dsir (Delivery System)Ino Therapeutics · 2013
- 1 generation backK131686 Inomax Dsir (Delivery System)Ino Therapeutics/Ikaria · 2013 · Recalled
- This deviceK143213 INOmax DSIR Plus MRIIno Therapeutics/Ikaria · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K003665 | Fadassi Medical FM-1 NO Blender | Fadasis Medical, Inc. | 2001 | — |
| −11 | K011874 | Fadasis Medical FM-1 NO Blender | Fadasis Medical, Inc. | 2001 | — |
| −10 | K052663 | Ino Therapeutics Inoblender, Model 10004 | Ino Therapeutics | 2005 | — |
| −9 | K061901 | Ino Therapeutics Inomax DS (Delivery System), Model 10003 | Ino Therapeutics | 2006 | 3 |
| −8 | K070867 | Inomax DS (Delivery System), Model 10003 | Ino Therapeutics, LLC | 2007 | — |
| −7 | K071516 | Inomax DS | Ino Therapeutics, LLC | 2007 | — |
| −6 | K080484 | Inomax DS (Delivery System), Model 10003 | Ino Therapeutics | 2008 | — |
| −5 | K110635 | Inomax DS (IR) (Delivery System) | Ino Therapeutics, LLC/Dba Ikaria | 2011 | — |
| −4 | K113272 | Inomax DS (Delivery Systems | Ino Therapeutics, LLC/Dba Ikaria | 2012 | — |
| −3 | K121021 | Inomax DS (Delivery System) | Ino Therapeutics | 2012 | — |
| −2 | K130605 | Inomax Dsir (Delivery System) | Ino Therapeutics | 2013 | — |
| −1 | K131686 | Inomax Dsir (Delivery System) | Ino Therapeutics/Ikaria | 2013 | 4 |
| 0 (this device) | K143213 | INOmax DSIR Plus MRI | Ino Therapeutics/Ikaria | 2015 | — |
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? (1)
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 |
|---|---|---|---|
| * | K131686 | Inomax Dsir (Delivery System)Summary page 4…Backup Delivery Device Classification: Class II – 21 CFR 868.5165 Product Code: MRN (Primary), MRO, MRP, MRQ Predicate Device(s) K131686 Ikaria 510(k) Premarket Notification INOmax DSIR Plus MRI Description of Dev… | 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 14 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 4 of the 20 ancestors have a recall of any class.
- 2 other devices also cite its predicate K131686.
How does its category compare?
All MRN devicesMRN Apparatus, Nitric Oxide Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 MRI delivery system is indicated for delivery of 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. The INOmax DSIR® Plus MRI is indicated for use only with MR Conditional ventilators validated to be compatible, as identified in the device…
Read the full statement (159 words)
The INOmax DSIR® Plus MRI delivery system is indicated for delivery of 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. The INOmax DSIR® Plus MRI is
indicated for use only with MR Conditional ventilators validated to be compatible, as identified in the device labeling.
The INOmax DSIR® Plus MRI is indicated for continuous integrated monitoring of inspired O2, NO2, and NO.
The INOmax DSIR® Plus MRI is considered MR Conditional with the use of 1.5 Tesla and 3.0 Tesla static magnetic field
scanners ONLY in areas where the field strength is less than 100 gauss.
The target patient population is controlled by the drug labeling for INOMAX® and is currently neonates. The primary
targeted clinical setting is a clinical 1.5 Tesla and 3.0 Tesla diagnostic imaging environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143213: INOmax DSIR Plus MRI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143213
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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