Evolve Nitric Oxide Delivery System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242578 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, supporting respiratory function and pulmonary vasodilation.
This system is intended for single-use in controlled clinical environments, such as operating rooms or intensive care units. It operates under FDA clearance (510K, K242578) and adheres to regulatory standards outlined in 21 CFR 868.5165. The device is supplied sterile and requires proper storage as specified in manufacturer instructions to maintain efficacy.
Frequently asked questions
What clinical settings is the Evolve Nitric Oxide Delivery System intended for use in?
The Evolve Nitric Oxide Delivery System is designed for use in controlled clinical environments where patients are under anesthesia or in critical care, such as operating rooms or intensive care units. Its purpose is to support respiratory function and promote pulmonary vasodilation through inhaled nitric oxide delivery.
Is the Evolve Nitric Oxide Delivery System meant for single-use or repeated use?
The Evolve Nitric Oxide Delivery System is explicitly intended for single-use only. This design ensures patient safety and maintains device efficacy, particularly in sterile environments like operating rooms or intensive care units.
How is the Evolve Nitric Oxide Delivery System supplied, and what does that mean for handling?
The device is supplied sterile, which means it is pre-sterilized and packaged to prevent contamination. This ensures it can be immediately used without additional sterilization steps, but proper storage as outlined in the manufacturer’s instructions must be followed to preserve sterility and functionality.
What regulatory pathway was followed for the FDA clearance of the Evolve Nitric Oxide Delivery System?
The Evolve Nitric Oxide Delivery System received FDA clearance through a 510(k) submission (K242578), classified as a Special clearance under the Anesthesiology advisory committee. The device was determined to be substantially equivalent to a predicate, adhering to regulatory standards outlined in 21 CFR 868.5165.
Are there multiple models or sizes available for the Evolve Nitric Oxide Delivery System?
The provided data does not specify distinct models or sizes for the Evolve Nitric Oxide Delivery System, but it is registered under multiple FEI numbers (e.g., 3012796317, 2518435, etc.), which may correspond to variations in packaging or configurations. For precise details on available options, refer to the manufacturer’s documentation or contact Mallinckrodt Manufacturing.
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, Delivery Systems | INOmax® (nitric oxide) gas, for inhalation, Mallinckrodt Announces an Expanded Rollout of the INOmax® EVOLVE™ DS ..., INOmax Evolve DS Nitric Oxide Delivery System | RT
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242578 | Class II | Active |
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Manufacturer
- Manufacturer
- Mallinckrodt Manufacturing, LLC
Sources (1)
- FDA 510(k) K242578 24 fields · synced Sep 19, 2026