# K120216: Genosyl MV-1000

- Pathway: 510(k) (Traditional)
- Applicant: Geno, LLC
- Decided: May 16, 2012 after 113 days
- Product code: MRN (Apparatus, Nitric Oxide Delivery)
- Device class: 2
- Regulation: 21 CFR 868.5165
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003665 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061901: Ino Therapeutics Inomax DS (Delivery System), Model 10003, Ino Therapeutics (2006) Summary page 1.

## Indications for use
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.,

Source page: https://510kreport.com/device/K120216
Methodology: https://510kreport.com/methodology