510(k) · Cleared
ClearedGenosyl MV-1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geno, LLC · MRN Apparatus, Nitric Oxide Delivery
Cleared on May 16, 2012 as substantially equivalent to K061901 (Ino Therapeutics, 2006) after a 113-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- May 16, 2012
- Review
- 113 days
- Class
- Class II
- Product code
- MRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K003665 (2001). 7 ancestors in all, the oldest K000186 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK003665 Fadassi Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
- 3 generations backK011874 Fadasis Medical FM-1 NO BlenderFadasis Medical, Inc. · 2001
- 2 generations backK052663 Ino Therapeutics Inoblender, Model 10004Ino Therapeutics · 2005
- 1 generation backK061901 Ino Therapeutics Inomax DS (Delivery System), Model 10003Ino Therapeutics · 2006 · Recalled
- This deviceK120216 Genosyl MV-1000Geno, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003665 | Fadassi Medical FM-1 NO Blender | Fadasis Medical, Inc. | 2001 | — |
| −3 | K011874 | Fadasis Medical FM-1 NO Blender | Fadasis Medical, Inc. | 2001 | — |
| −2 | K052663 | Ino Therapeutics Inoblender, Model 10004 | Ino Therapeutics | 2005 | — |
| −1 | K061901 | Ino Therapeutics Inomax DS (Delivery System), Model 10003 | Ino Therapeutics | 2006 | 3 |
| 0 (this device) | K120216 | Genosyl MV-1000 | Geno, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K061901 | Ino Therapeutics Inomax DS (Delivery System), Model 10003Summary page 1…868.2385 Nitrogen dioxide gas analyzer Class: All are Class 2 Predicate Devices: Ikaria INOmax DS - K061901 Device Description: GeNOsyl MV-10OO Delivery System includes four components: 1. Nitric oxide administration apparatus, pri… | 2006 |
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 11 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 13 other devices also cite its predicate K061901.
How does its category compare?
All MRN devicesMRN Apparatus, Nitric Oxide Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 GeNOsyTM MV-1000 delivers nitric oxide (NO) for 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. It is indicated to be used with the Bio-Med Devices CV-2± ventilator. It provides continuous integrated monitoring of inspired 02, NO2 , and NO, and a comprehensive alarm system. It incorporates a battery that provides up to 1 hour of…
Read the full statement (126 words)
The GeNOsyTM MV-1000 delivers nitric oxide (NO) for 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.
It is indicated to be used with the Bio-Med Devices CV-2± ventilator.
It provides continuous integrated monitoring of inspired 02, NO2 , and NO, and a comprehensive alarm system.
It incorporates a battery that provides up to 1 hour of uninterrupted NO delivery in the absence of an external power source.
It 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 patient's breathing circuit.,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120216 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120216: Genosyl MV-1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120216
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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