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Evolve Nitric Oxide Delivery System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K222930

by Mallinckrodt Manufacturing, LLC

Identifiers

510(k) Number
K222930 FDA 510(k)
FDA Product Code
MRN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5165 FDA 510(k)
Regulation Number
868.5165 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Evolve Nitric Oxide Delivery System is an Apparatus for Nitric Oxide Delivery, classified as a Class II medical device. It is designed to administer inhaled nitric oxide (NO) gas to patients under anesthesia or critical care settings, facilitating vasodilation and improving oxygenation in conditions such as pulmonary hypertension or acute respiratory distress syndrome. The device operates by delivering precise concentrations of NO through a controlled inhalation process, ensuring therapeutic dosing while minimizing exposure to ambient air contamination.

This system is intended for use in anesthesiology and critical care environments, supplied as a reusable medical device with FDA clearance under 510K (K222930). It adheres to regulatory standards outlined in 21 CFR 868.5165, ensuring compliance with safety and performance requirements. The device is not sterile and must be cleaned and maintained according to manufacturer instructions. No MRI safety information is specified, and its use is restricted to authorized healthcare professionals following established protocols.

Frequently asked questions

Is the Evolve Nitric Oxide Delivery System intended for single-use or can it be reused in a clinical setting?

The Evolve Nitric Oxide Delivery System is designed as a reusable medical device. Since it is not sterile, it must be cleaned and maintained according to the manufacturer’s instructions to ensure safe and effective use across multiple patients in anesthesiology or critical care settings.

What types of clinical environments is this device approved for, and what conditions does it address?

The Evolve Nitric Oxide Delivery System is FDA-cleared for use in anesthesiology and critical care environments, where it delivers inhaled nitric oxide (NO) gas to promote vasodilation and improve oxygenation. It is specifically intended for patients with conditions like pulmonary hypertension or acute respiratory distress syndrome (ARDS), though the exact clinical indications are determined by authorized healthcare professionals following established protocols.

How is the device supplied, and what should be considered regarding its storage or handling?

The Evolve Nitric Oxide Delivery System is supplied as a reusable device, meaning it is not sterile out-of-the-box. Since it requires cleaning and maintenance, facilities must follow the manufacturer’s guidelines to prevent contamination and ensure proper functionality. Storage should be in a clean, dry environment away from direct sunlight or extreme temperatures to maintain device integrity.

Does this device have any specific regulatory or advisory committee associations, and how does that affect its use?

The Evolve Nitric Oxide Delivery System was reviewed by the FDA’s Anesthesiology (AN) Advisory Committee and granted 510(k) clearance (K222930) under the Medical Specialty Description of Anesthesiology. This classification means it is intended for use only by authorized healthcare professionals in controlled settings, such as operating rooms or intensive care units, where nitric oxide therapy is administered under strict protocols.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: INOmax EVOLVE™ DS | INOmax® (nitric oxide) gas, for inhalation, Mallinckrodt Announces an Expanded Rollout of the INOmax® EVOLVE™ DS ..., Delivery Systems | INOmax® (nitric oxide) gas, for inhalation, INOmax Evolve DS Nitric Oxide Delivery System | RT

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mallinckrodt Manufacturing, LLC

Sources (1)

  • FDA 510(k) K222930 24 fields · synced Sep 20, 2026