510(k) · Cleared
Recalled · Class II · 2018Inomax Dsir (Delivery System)
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 Nov 29, 2013 as substantially equivalent to K061901 (Ino Therapeutics, 2006) and 12 other predicates after a 172-day review. Its family tree reaches back 11 generations to 2001. 5 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 29, 2013
- Review
- 172 days
- Class
- Class II
- Product code
- MRN
- Recalls
- 4
- Predicates
- 13
Its longest line of descent runs back 11 generations to K003665 (2001). 19 ancestors in all, the oldest K000186 (2000). 5 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK003665 Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
- 7 generations between
- 3 generations backK113272 Inomax DS (Delivery SystemsIno Therapeutics, LLC/Dba Ikaria · 2012
- 2 generations backK121021 Inomax DS (Delivery System)Ino Therapeutics · 2012
- 1 generation backK130605 Inomax Dsir (Delivery System)Ino Therapeutics · 2013
- This deviceK131686 Inomax Dsir (Delivery System)Ino Therapeutics/Ikaria · 2013
- Descendant · cites it directly · 3 of its ownK200389 INOmax DSIR PlusMallinckrodt Manufacturing, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK212409 Ulspira TS Nitric Oxide Therapy SystemAirgas Therapeutics · 2023
- Descendant · 3 generations on · 0 of its ownK242374 ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLC · 2025
- Descendant · cites it directly · 0 of its ownK211153 Inomax DSIRMallinckrodt Manufacturing, LLC · 2023
- Descendant · cites it directly · 0 of its ownK143213 INOmax DSIR Plus MRIIno Therapeutics/Ikaria · 2015
Show all 11 generations
- Root · 11 generations backK003665 Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
- 10 generations backK011874 Fadasis Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
- 9 generations backK052663 Ino Therapeutics Inoblender, Model 10004Ino Therapeutics · 2005
- 8 generations backK061901 Ino Therapeutics Inomax DS (Delivery System), Model 10003Ino Therapeutics · 2006 · Recalled
- 7 generations backK070867 Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC · 2007
- 6 generations backK071516 Inomax DSIno Therapeutics, LLC · 2007
- 5 generations backK080484 Inomax DS (Delivery System), Model 10003Ino Therapeutics · 2008
- 4 generations backK110635 Inomax DS (IR) (Delivery System)Ino Therapeutics, LLC/Dba Ikaria · 2011
- 3 generations backK113272 Inomax DS (Delivery SystemsIno Therapeutics, LLC/Dba Ikaria · 2012
- 2 generations backK121021 Inomax DS (Delivery System)Ino Therapeutics · 2012
- 1 generation backK130605 Inomax Dsir (Delivery System)Ino Therapeutics · 2013
- This deviceK131686 Inomax Dsir (Delivery System)Ino Therapeutics/Ikaria · 2013
Most influential descendants
Showing 5 of 5 · See all- K200389INOmax DSIR PlusMallinckrodt Manufacturing, LLC · 2020 · cites it directly3descendants
- K212409Ulspira TS Nitric Oxide Therapy SystemAirgas Therapeutics · 2023 · 2 generations on1descendant
- K242374ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLC · 2025 · 3 generations on0descendants
- K211153Inomax DSIRMallinckrodt Manufacturing, LLC · 2023 · cites it directly0descendants
- K143213INOmax DSIR Plus MRIIno Therapeutics/Ikaria · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K003665 | Fadassi Medical FM-1 NO Blender | Fadasis Medical, Inc. | 2001 | — |
| −10 | K011874 | Fadasis Medical FM-1 NO Blender | Fadasis Medical, Inc. | 2001 | — |
| −9 | K052663 | Ino Therapeutics Inoblender, Model 10004 | Ino Therapeutics | 2005 | — |
| −8 | K061901 | Ino Therapeutics Inomax DS (Delivery System), Model 10003 | Ino Therapeutics | 2006 | 3 |
| −7 | K070867 | Inomax DS (Delivery System), Model 10003 | Ino Therapeutics, LLC | 2007 | — |
| −6 | K071516 | Inomax DS | Ino Therapeutics, LLC | 2007 | — |
| −5 | K080484 | Inomax DS (Delivery System), Model 10003 | Ino Therapeutics | 2008 | — |
| −4 | K110635 | Inomax DS (IR) (Delivery System) | Ino Therapeutics, LLC/Dba Ikaria | 2011 | — |
| −3 | K113272 | Inomax DS (Delivery Systems | Ino Therapeutics, LLC/Dba Ikaria | 2012 | — |
| −2 | K121021 | Inomax DS (Delivery System) | Ino Therapeutics | 2012 | — |
| −1 | K130605 | Inomax Dsir (Delivery System) | Ino Therapeutics | 2013 | — |
| 0 (this device) | K131686 | Inomax Dsir (Delivery System) | Ino Therapeutics/Ikaria | 2013 | — |
| +1 | K200389 | INOmax DSIR Plus | Mallinckrodt Manufacturing, LLC | 2020 | — |
| +2 | K212409 | Ulspira TS Nitric Oxide Therapy System | Airgas Therapeutics | 2023 | — |
| +3 | K242374 | ULSPIRA TS™ Nitric Oxide Therapy System | Airgas Therapeutics, LLC | 2025 | — |
| +1 | K211153 | Inomax DSIR | Mallinckrodt Manufacturing, LLC | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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? (13)
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 |
|---|---|---|---|
| * | K061901 | Ino Therapeutics Inomax DS (Delivery System), Model 10003Summary page 1…Device Classification: Class 11 -21 CFR 868.5165 Product Code: MRN (Primary), MRO, MRP, MRQ Predicate Device(s) K06 190 1, K070867, K07 1516, K080484, K08 169 1, K090958, K092545, K093922, KI 10344, KI 10635,… | 2006 |
| * | K070867 | Inomax DS (Delivery System), Model 10003Summary page 1…assification: Class 11 -21 CFR 868.5165 Product Code: MRN (Primary), MRO, MRP, MRQ Predicate Device(s) K06 190 1, K070867, K07 1516, K080484, K08 169 1, K090958, K092545, K093922, KI 10344, KI 10635,… | 2007 |
| * | K071516 | Inomax DSSummary page 1…ion: Class 11 -21 CFR 868.5165 Product Code: MRN (Primary), MRO, MRP, MRQ Predicate Device(s) K06 190 1, K070867, K07 1516, K080484, K08 169 1, K090958, K092545, K093922, KI 10344, KI 10635,… | 2007 |
| * | K080484 | Inomax DS (Delivery System), Model 10003Summary page 1…Class 11 -21 CFR 868.5165 Product Code: MRN (Primary), MRO, MRP, MRQ Predicate Device(s) K06 190 1, K070867, K07 1516, K080484, K08 169 1, K090958, K092545, K093922, KI 10344, KI 10635,… | 2008 |
| * | K081691 | Inomax DS (Delivery System)Summary page 1…11 -21 CFR 868.5165 Product Code: MRN (Primary), MRO, MRP, MRQ Predicate Device(s) K06 190 1, K070867, K07 1516, K080484, K08 169 1, K090958, K092545, K093922, KI 10344, KI 10635, K… | 2008 |
| * | K090958 | Inomax DS (Delivery System)Summary page 1…MRN (Primary), MRO, MRP, MRQ Predicate Device(s) K06 190 1, K070867, K07 1516, K080484, K08 169 1, K090958, K092545, K093922, KI 10344, KI 10635, KI 113272, K12102 1, K130605 Description of Devic… | 2009 |
| * | K092545 | Inomax DS (Delivery System), Model 10003Summary page 1…MRN (Primary), MRO, MRP, MRQ Predicate Device(s) K06 190 1, K070867, K07 1516, K080484, K08 169 1, K090958, K092545, K093922, KI 10344, KI 10635, KI 113272, K12102 1, K130605 Description of Device Th… | 2010 |
| * | K093922 | Inomax DSSummary page 1…mary), MRO, MRP, MRQ Predicate Device(s) K06 190 1, K070867, K07 1516, K080484, K08 169 1, K090958, K092545, K093922, KI 10344, KI 10635, KI 113272, K12102 1, K130605 Description of Device The INOmax… | 2010 |
| * | K110344 | Inomax Dsir (Delivery System) | 2011 |
| * | K110635 | Inomax DS (IR) (Delivery System) | 2011 |
| * | K113272 | Inomax DS (Delivery SystemsSummary page 1…K070867, K07 1516, K080484, K08 169 1, K090958, K092545, K093922, KI 10344, KI 10635, KI 113272, K12102 1, K130605 Description of Device The INOmax DSIR®I uses a "dual-channel' design to ensure the safe… | 2012 |
| * | K121021 | Inomax DS (Delivery System)Summary page 1…, K07 1516, K080484, K08 169 1, K090958, K092545, K093922, KI 10344, KI 10635, KI 113272, K12102 1, K130605 Description of Device The INOmax DSIR®I uses a "dual-channel' design to ensure the safe… | 2012 |
| * | K130605 | Inomax Dsir (Delivery System)Summary page 1…, K080484, K08 169 1, K090958, K092545, K093922, KI 10344, KI 10635, KI 113272, K12102 1, K130605 Description of Device The INOmax DSIR®I uses a "dual-channel' design to ensure the safe delivery… | 2013 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 9, 2018 | Class II | Z-2733-2018 | Process control | INOmeters affixed to the INOflo cylinders in Lot 17FP-0570 were programmed with an incorrect expiration date (11/2017). For Lot 17FP-0570, the label affixed to each INOflo cylinder has the correct expiration date noted (11/2020). |
| Nov 21, 2016 | Class II | Z-1076-2017 | Equipment maintenance | Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve calibration table in an affected device. |
| Oct 17, 2014 | Class II | Z-0575-2015 | Process change control | An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected. This issue only pertains to those devices manufactured using a specific version of the… |
| Mar 27, 2014 | Class II | Z-1528-2014 | Software Design Change | An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrated pneumatic backup switch is activated with low or no gas flow through the injector module, an intended NO cell failure alarm will occur. In… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 7 months on median.
- 3 of the 19 ancestors have a recall of any class.
- Of its descendants, K200389 (Mallinckrodt Manufacturing, LLC, 2020) has gone furthest, with 3 descendants of its own.
- 13 other devices also cite its predicate K061901.
How does its category compare?
All MRN devicesMRN Apparatus, Nitric Oxide Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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* DS delivery system delivers INOMvAXO (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…
Read the full statement (204 words)
The INOmax* DS delivery system delivers INOMvAXO (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 most ventilators.
The INOmaxDS Orovides continuous integrated monitoring of inspired 02, N02, and NO, and a comprehensive alarm system.
The iNOmaxv DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.
The INOmaxo DS includes a backup NO delivery capability that provides a fixe'dflow of 250 niL/min of NO which along with user supplied 10 Llnin of oxygen provides 20 ppm in the gas flow to a patients breathing circuit. It may also use the lNOblendero for backup.
The target patient population is controlled by the drug labeling for INOMAXO and is currently neonates. 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/K131686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131686: Inomax Dsir (Delivery System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131686
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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