510(k) · Cleared
Recalled · Class II · 2022Ino Therapeutics Inomax DS (Delivery System), Model 10003
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ino Therapeutics · MRN Apparatus, Nitric Oxide Delivery
Cleared on Dec 14, 2006 as substantially equivalent to K000186 (Datex-Ohmeda, 2000) and 3 other predicates after a 162-day review. Its family tree reaches back 3 generations to 2001. 5 of the 31 devices in its family, counting itself, have a Class I recall. 24 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 14, 2006
- Review
- 162 days
- Class
- Class II
- Product code
- MRN
- Recalls
- 3
- Predicates
- 5
Its longest line of descent runs back 3 generations to K003665 (2001). 6 ancestors in all, the oldest K000186 (2000). 24 later devices descend from it, 14 citing it directly. 5 of the 31 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK003665 Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
- 2 generations backK011874 Fadasis Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
- 1 generation backK052663 Ino Therapeutics Inoblender, Model 10004Ino Therapeutics · 2005
- This deviceK061901 Ino Therapeutics Inomax DS (Delivery System), Model 10003Ino Therapeutics · 2006
- Descendant · cites it directly · 16 of its ownK092545 Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC · 2010
- Descendant · cites it directly · 15 of its ownK070867 Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC · 2007
- Descendant · cites it directly · 14 of its ownK071516 Inomax DSIno Therapeutics, LLC · 2007
- Descendant · cites it directly · 11 of its ownK093922 Inomax DSIno Therapeutics · 2010 · Recalled
- Descendant · cites it directly · 11 of its ownK090958 Inomax DS (Delivery System)Ino Therapeutics, LLC · 2009
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 24 · See all- K092545Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC · 2010 · cites it directly16descendants
- K070867Inomax DS (Delivery System), Model 10003Ino Therapeutics, LLC · 2007 · cites it directly15descendants
- K071516Inomax DSIno Therapeutics, LLC · 2007 · cites it directly14descendants
- K093922Inomax DSIno Therapeutics · 2010 · cites it directly11descendants
- K090958Inomax DS (Delivery System)Ino Therapeutics, LLC · 2009 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003665 | Fadassi Medical FM-1 NO Blender | Fadasis Medical, Inc. | 2001 | — |
| −2 | K011874 | Fadasis Medical FM-1 NO Blender | Fadasis Medical, Inc. | 2001 | — |
| −1 | K052663 | Ino Therapeutics Inoblender, Model 10004 | Ino Therapeutics | 2005 | — |
| 0 (this device) | K061901 | Ino Therapeutics Inomax DS (Delivery System), Model 10003 | Ino Therapeutics | 2006 | — |
| +1 | K092545 | Inomax DS (Delivery System), Model 10003 | Ino Therapeutics, LLC | 2010 | — |
| +1 | K070867 | Inomax DS (Delivery System), Model 10003 | Ino Therapeutics, LLC | 2007 | — |
| +1 | K071516 | Inomax DS | Ino Therapeutics, LLC | 2007 | — |
| +1 | K093922 | Inomax DS | Ino Therapeutics | 2010 | 1 |
| +1 | K090958 | Inomax DS (Delivery System) | Ino Therapeutics, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 1 |
| 2020 | 2 | 1 |
| 2022 | 1 | 1 |
| 2023 | 3 | 1 |
| 2024 | 1 | 1 |
| 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.
5 devices in this family have a Class I recall. 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K974562 | Ohmeda INOvent Delivery System (now GE Healthcare) Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…anel: Anesthesiology Predicate Device(s): Ohmeda INOvent Delivery System (now GE Healthcare) (primary) 510(k) Number K974562 Datex-Ohmeda INOvent Delivery System (now GE Healthcare) 510(k) Number K00… | |
| * | K000186 | Datex-Ohmeda Inovent Delivery SystemSummary page 1…510(k) Number K974562 Datex-Ohmeda INOvent Delivery System (now GE Healthcare) 510(k) Number K000186 INO Therapeutics INOblender 510(k) Number K052663… | 2000 |
| * | K052663 | Ino Therapeutics Inoblender, Model 10004Summary page 1…(now GE Healthcare) 510(k) Number K000186 INO Therapeutics INOblender 510(k) Number K052663 Pulmonox Vianox Delivery System (now SensorMedics) 510(k) Number K023014… | 2005 |
| * | K023014 | Vianox Delivery System, Model ISummary page 1…510(k) Number K052663 Pulmonox Vianox Delivery System (now SensorMedics) 510(k) Number K023014 Pulmonox Aeronox Delivery System (now SensorMedics) 5 10(k) Number K000653… | 2003 |
| * | K000653 | Aeronox Universal, Model P/N 360000, Aeronox Bedside, Model P/N 360001, Aeronox…Summary page 1…510(k) Number K023014 Pulmonox Aeronox Delivery System (now SensorMedics) 5 10(k) Number K000653 Patient Population: The targeted patient population is neonates. This is derived from the… | 2000 |
What descends from it? (24)
See all 2414 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092545 | Inomax DS (Delivery System), Model 10003 | 2010 | 16 |
| K070867 | Inomax DS (Delivery System), Model 10003 | 2007 | 15 |
| K071516 | Inomax DS | 2007 | 14 |
| K093922 | Inomax DS | 2010 | 11 |
| K090958 | Inomax DS (Delivery System) | 2009 | 11 |
| K081691 | Inomax DS (Delivery System) | 2008 | 11 |
| K080484 | Inomax DS (Delivery System), Model 10003 | 2008 | 11 |
| K110344 | Inomax Dsir (Delivery System) | 2011 | 9 |
| K110635 | Inomax DS (IR) (Delivery System) | 2011 | 9 |
| K113272 | Inomax DS (Delivery Systems | 2012 | 8 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 23, 2022 | Class II | Z-1745-2022 | Under Investigation by firm | The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein Medical. The Leoni Plus ventilator was recently upgraded… |
| Nov 30, 2010 | Not classified | Z-0583-2012 | Nonconforming Material/Component | Through the review and monitoring of its complaint data, Ikaria identified a product anomaly with the INOmax DS Model 1003. Ikaria concluded the anomaly risk to the patient safety was low and non reportable (4/23/10). During a subsequent… |
| Jul 21, 2010 | Not classified | Z-2176-2010 | Component design/selection | The pressure switch in the INOMAX DS drug-delivery system may fail, which may interrupt or delay the administration of INOMAX (nitric oxide) for inhalation to patients. Delay in administration of INOMAX therapy may cause: -worsening of… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K171696NOxBOXi Nitric Oxide Delivery SystemPraxair Distribution, Inc. · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 13 Class I recalls
- K220898NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2022 · 3 generations on · ◆ in the 2022 descendants bar of FIG. 12 Class I recalls
- K201339The NOxBOXi Nitric Oxide Delivery SystemPraxair, Inc. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 12 Class I recalls
- K231823NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
- K233251NOxBOXi Nitric Oxide Delivery SystemLinde Gas & Equipment, Inc. · 2024 · 5 generations on · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K092545 (Ino Therapeutics, LLC, 2010) has gone furthest, with 16 descendants of its own.
How does its category compare?
All MRN devicesMRN Apparatus, Nitric Oxide Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 INOmax® (nitric oxide of 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 (207 words)
The INOmax DS delivery system delivers INOmax® (nitric oxide of 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 INOmax DS provides continuous integrated monitoring of inspired 02, NO 2, and NO, and a comprehensive alarm system.
The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.
The INOmax DS 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 1NOblender for backup.
The target patient population is controlled by the drug labeling for INOmax 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/K061901 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061901: Ino Therapeutics Inomax DS (Delivery System), Model 10003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061901
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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