510(k) · Cleared
ClearedEvolve Nitric Oxide Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mallinckrodt Manufacturing, LLC · MRN Apparatus, Nitric Oxide Delivery
Cleared on Dec 6, 2023 after a 436-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Dec 6, 2023
- Review
- 436 days
- Class
- Class II
- Product code
- MRN
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK222930 Evolve Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLC · 2023
- Descendant · cites it directly · 1 of its ownK240410 EVOLVE Nitric Oxide Delivery SystemMalinckrodt Manufacturing, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK242578 EVOLVE Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLC · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K222930 | Evolve Nitric Oxide Delivery System | Mallinckrodt Manufacturing, LLC | 2023 | — |
| +1 | K240410 | EVOLVE Nitric Oxide Delivery System | Malinckrodt Manufacturing, LLC | 2024 | — |
| +2 | K242578 | EVOLVE Nitric Oxide Delivery System | Mallinckrodt Manufacturing, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240410 | EVOLVE Nitric Oxide Delivery System | 2024 | 1 |
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?
- Of its descendants, K240410 (Malinckrodt Manufacturing, LLC, 2024) has gone furthest, with 1 descendant 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. 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 | — |
https://510kreport.com/device/K222930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222930: Evolve Nitric Oxide 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/K222930
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026