Cleared Special

K240410 - EVOLVE Nitric Oxide Delivery System (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K240410 · Malinckrodt Manufacturing, LLC · Anesthesiology device
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May 2024
Decision
106d
Days
Class 2
Risk

K240410 is an FDA 510(k) clearance for the EVOLVE Nitric Oxide Delivery System. Classified as Apparatus, Nitric Oxide Delivery (product code MRN), Class II - Special Controls.

Submitted by Malinckrodt Manufacturing, LLC (Madison, US). The FDA issued a Cleared decision on May 28, 2024 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5165 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Malinckrodt Manufacturing, LLC devices

Submission Details

510(k) Number K240410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2024
Decision Date May 28, 2024
Days to Decision 106 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 139d · This submission: 106d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MRN Apparatus, Nitric Oxide Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5165
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - MRN Apparatus, Nitric Oxide Delivery

All 32
Devices cleared under the same product code (MRN) and FDA review panel - the closest regulatory comparables to K240410.
ULSPIRA TS™ Nitric Oxide Therapy System
K242374 · Airgas Therapeutics, LLC · Jan 2025
EVOLVE Nitric Oxide Delivery System
K242578 · Mallinckrodt Manufacturing, LLC · Jan 2025
NOxBOXi Nitric Oxide Delivery System
K233251 · Linde Gas & Equipment, Inc. · May 2024
Evolve Nitric Oxide Delivery System
K222930 · Mallinckrodt Manufacturing, LLC · Dec 2023
NOxBOXi Nitric Oxide Delivery System
K231823 · Linde Gas & Equipment, Inc. · Aug 2023
Ulspira TS Nitric Oxide Therapy System
K212409 · Airgas Therapeutics · Jun 2023