# K242578: EVOLVE Nitric Oxide Delivery System

- Pathway: 510(k) (Special)
- Applicant: Mallinckrodt Manufacturing, LLC
- Decided: Jan 3, 2025 after 127 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: 2 generations back to K222930 (2023). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240410: EVOLVE Nitric Oxide Delivery System, Malinckrodt Manufacturing, LLC (2024) Summary page 6.

## Indications for use
The Evolve DS (delivery system) delivers INOMAX® (nitric oxide 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, to the patient throughout the inspired breath. It uses a specially designed Injector Module, which enables tracking of the gas delivery system waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with ventilators and respiratory care devices for which the Evolve DS has been validated. The Evolve DS provides continuous integrated monitoring of inspired NO2 and NO with a comprehensive alarm system. The Evolve DS also provides monitoring and alarms for the drug delivery system. The Evolve DS incorporates a battery that provides up to 4 hours of uninterrupted NO delivery in the absence of external power. The Evolve DS also incorporates an integrated electronic blender that functions as a backup delivery device to provide an adjustable INOmax dose with user supplied oxygen to a manual resuscitator or gas delivery system. The electronic blender incorporates a separate control and delivery pathway that serves as a redundant mechanism for nitric oxide delivery in the event of a main system fault. The Evolve DS must only be used in accordance with the indications, contraindications, warnings and precautions described in the nitric oxide drug packaging inserts and labeling and is indicated for use in term and near-term (>34weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. The Evolve DS is indicated for a maximum of 14 days use. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU), and secondary targeted clinical setting is the transport of neonates.

Source page: https://510kreport.com/device/K242578
Methodology: https://510kreport.com/methodology