510(k) · Cleared
ClearedUlspira TS Nitric Oxide Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airgas Therapeutics · MRN Apparatus, Nitric Oxide Delivery
Cleared on Jun 30, 2023 as substantially equivalent to K200389 (Mallinckrodt Manufacturing, LLC, 2020) after a 696-day review. Its family tree reaches back 13 generations to 2001. 1 later device descends from it.
- Decided
- Jun 30, 2023
- Review
- 696 days
- Class
- Class II
- Product code
- MRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K003665 (2001). 21 ancestors in all, the oldest K000186 (2000). 1 later device descends from it, 1 citing it directly.
- 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 deviceK212409 Ulspira TS Nitric Oxide Therapy SystemAirgas Therapeutics · 2023
- Descendant · cites it directly · 0 of its ownK242374 ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLC · 2025
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 deviceK212409 Ulspira TS Nitric Oxide Therapy SystemAirgas Therapeutics · 2023
Most influential descendants
Showing 1 of 1 · See all- K242374ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLC · 2025 · cites it directly0descendants
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) | K212409 | Ulspira TS Nitric Oxide Therapy System | Airgas Therapeutics | 2023 | — |
| +1 | K242374 | ULSPIRA TS™ Nitric Oxide Therapy System | Airgas Therapeutics, LLC | 2025 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K200389 | INOmax DSIR PlusSummary page 5…Page 1 of 12 Product Codes: MRN (Primary), MRO, MRP, MRQ, CCL D. PREDICATE DEVICE K200389, INOmax DSIR Plus E. REFERENCE DEVICE(S) K171696, NOxBOXi Nitric Oxide Delivery System… | 2020 |
| † | K171696 | NOxBOXi Nitric Oxide Delivery System | 2018 |
| † | K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242374 | ULSPIRA TS™ Nitric Oxide Therapy System | 2025 | 0 |
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 7 companies; a new generation was cleared every 8 months on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K242374 (Airgas Therapeutics, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 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 Ulspira TS Nitric Oxide Therapy System is intended for use by healthcare professionals for the delivery of nitric oxide (NO) and the monitoring of inspired NO, NO2 and O2 concentrations for a patient undergoing inhaled Nitric Oxide (iNO) therapy. The Ulspira TS 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…
Read the full statement (318 words)
The Ulspira TS Nitric Oxide Therapy System is intended for use by healthcare professionals for the delivery of nitric oxide (NO) and the monitoring of inspired NO, NO2 and O2 concentrations for a patient undergoing inhaled Nitric Oxide (iNO) therapy.
The Ulspira TS 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. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates. Refer to this material prior to use.
The Ulspira TS primary NO therapy system delivers NO gas in the 0-80 ppm range while in the Constant Rate or flow sensing modes. This includes:
• Continuous integrated monitoring for inspired NO, NO2 and O2 and a comprehensive alarm system.
• A touch-screen user interface with a waveform display of the ventilation device flow as measured in the inspiratory limb.
• Cylinder handling facilitated by manual or an automatic cylinder switch which is reactive to the detected gas supply state of NO cylinders, and a low O2 pressure alarm when using an oxygen cylinder.
• An automated emergency dosing algorithm activated by certain high-risk alarms, which impact patient dosing, to avoid sudden cessation of therapy.
• Compatibility with a wide inspiratory flow rate range of 0.25-120 l/min, utilizing an automatically detected low or high flow sensor.
• An internal battery which provides at least two hours of uninterrupted therapy and a 12V DC inlet for additional external battery access.
The integrated Ulspira TS pneumatic backup NO therapy system provides backup NO delivery capability that is intended to deliver a continuous flow of NO mixed with O2, for iNO therapy which allows continuous treatment during transit within hospitals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212409 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212409: Ulspira TS Nitric Oxide Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212409
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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