Cleared Traditional

Evolve Nitric Oxide Delivery System

K222930 · Mallinckrodt Manufacturing, LLC · Anesthesiology

Dec 2023

Decision

436d

Days

Class 2

Risk

About This 510(k) Submission

K222930 is an FDA 510(k) clearance for the Evolve Nitric Oxide Delivery System, a Apparatus, Nitric Oxide Delivery (Class II — Special Controls, product code MRN), submitted by Mallinckrodt Manufacturing, LLC (Madison, US). The FDA issued a Cleared decision on December 6, 2023, 436 days after receiving the submission on September 26, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5165.

Submission Details

510(k) Number	K222930 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2022
Decision Date	December 06, 2023
Days to Decision	436 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF