510(k) · Cleared
ClearedAeronox Nitric Oxide Titration & Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Biomedical, Ltd. · MRN Apparatus, Nitric Oxide Delivery
Cleared on Dec 16, 2009 as substantially equivalent to K000653 (Pulmonox Medical Corp., 2000) after a 58-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Dec 16, 2009
- Review
- 58 days
- Class
- Class II
- Product code
- MRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000653 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK000653 Aeronox Universal, Model P/N 360000, Aeronox Bedside, Model P/N…Pulmonox Medical Corp. · 2000
- This deviceK093260 Aeronox Nitric Oxide Titration & Monitoring SystemInternational Biomedical, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK193481 AeroNOx 2.0 Nitric Oxide Titration & Monitoring SystemInternational Biomedical · 2020
Most influential descendants
Showing 1 of 1 · See all- K193481AeroNOx 2.0 Nitric Oxide Titration & Monitoring SystemInternational Biomedical · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000653 | Aeronox Universal, Model P/N 360000, Aeronox Bedside, Model P/N 360001… | Pulmonox Medical Corp. | 2000 | — |
| 0 (this device) | K093260 | Aeronox Nitric Oxide Titration & Monitoring System | International Biomedical, Ltd. | 2009 | — |
| +1 | K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | International Biomedical | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K000653 | Aeronox Universal, Model P/N 360000, Aeronox Bedside, Model P/N 360001, Aeronox…Summary page 1…Product Code MRN, Anesthesiology. 4. Predicate Device Information: The predicate device is the AeroNOx Nitric Oxide Titration & Monitoring System, K000653, 8/4/00. 5. Labeling: The product labeling has been changed to add three additional ventilators to the list of val… | 2000 |
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 |
|---|---|---|---|
| K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | 2020 | 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?
How does its category compare?
All MRN devicesMRN Apparatus, Nitric Oxide Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 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 is also intended to be used with a flow inflating manual ventilator (an AeroNOx accessory), by introducing controlled flows of…
Read the full statement (119 words)
The AeroNOx 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 is also intended to be used with a flow inflating manual ventilator (an AeroNOx 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 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/K093260 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093260: Aeronox Nitric Oxide Titration & Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093260
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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