510(k) · Cleared
ClearedAeroNOx 2.0 Nitric Oxide Titration & Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Biomedical · MRN Apparatus, Nitric Oxide Delivery
Cleared on Mar 10, 2020 as substantially equivalent to K093260 (International Biomedical, Ltd., 2009) after an 84-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Mar 10, 2020
- Review
- 84 days
- Class
- Class II
- Product code
- MRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000653 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK000653 Aeronox Universal, Model P/N 360000, Aeronox Bedside, Model P/N…Pulmonox Medical Corp. · 2000
- 1 generation backK093260 Aeronox Nitric Oxide Titration & Monitoring SystemInternational Biomedical, Ltd. · 2009
- This deviceK193481 AeroNOx 2.0 Nitric Oxide Titration & Monitoring SystemInternational Biomedical · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000653 | Aeronox Universal, Model P/N 360000, Aeronox Bedside, Model P/N 360001… | Pulmonox Medical Corp. | 2000 | — |
| −1 | K093260 | Aeronox Nitric Oxide Titration & Monitoring System | International Biomedical, Ltd. | 2009 | — |
| 0 (this device) | K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | International Biomedical | 2020 | — |
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 |
|---|---|---|---|
| * | K093260 | Aeronox Nitric Oxide Titration & Monitoring SystemSummary page 4…s: II Regulation: 868.5165 Product Code: MRN Panel: Anesthesiology Predicate Device: AeroNOx 2.0 Nitric Oxide Titration & Monitoring System (K093260) Device Description: The AeroNOx 2.0 nitric oxide delivery system is specifically designed for the transmission an… | 2009 |
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 20 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All MRN devicesMRN Apparatus, Nitric Oxide Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 AeroNOx 2.0 is intended to provide a constant controlled concentration of nitric oxide in breathing gas by delivering a constant controlled flow of nitric oxide into the inspiratory limb of a mechanical ventilator that operates using a continuous constant flow of fresh gas into the inspiratory limb of the ventilator. The AeroNOx 2.0 is also intended to be used with a flow inflating manual ventilator (an AeroNOx 2.0 accessory), by introducing…
Read the full statement (123 words)
The AeroNOx 2.0 is intended to provide a constant controlled concentration of nitric oxide in breathing gas by delivering a constant controlled flow of nitric oxide into the inspiratory limb of a mechanical ventilator that operates using a continuous constant flow of fresh gas into the inspiratory limb of the ventilator. The AeroNOx 2.0 is also intended to be used with a flow inflating manual ventilator (an AeroNOx 2.0 accessory), by introducing controlled flows of nitric oxide into the fresh gas flow to the manual ventilator. It is also intended to monitor nitric oxide, nitrogen dioxide, and oxygen concentrations in the breathing gas.
The AeroNOx 2.0 is intended to be used within a hospital or during air or ground transport outside the hospital.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193481: AeroNOx 2.0 Nitric Oxide Titration & Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193481
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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