EVOLVE Nitric Oxide Delivery System

FDA 510(k) K242578 · Mallinckrodt Manufacturing, LLC

Substantially Equivalent

510(k) numberK242578

Submission

Device name
EVOLVE Nitric Oxide Delivery System
Applicant
Mallinckrodt Manufacturing, LLC
Madison, WI, US
Received
August 29, 2024
Decision date
January 3, 2025
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MRN – Apparatus, Nitric Oxide Delivery
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5165
Specialty
Anesthesiology
Life-sustaining
Yes

Other 510(k)s with product code MRN

510(k)DeviceApplicantDecision
K242374ULSPIRA TS™ Nitric Oxide Therapy SystemMRN · Special Airgas Therapeutics, LLC01/17/2025SE
K240410EVOLVE Nitric Oxide Delivery SystemMRN · Special Malinckrodt Manufacturing, LLC05/28/2024SE
K233251NOxBOXi Nitric Oxide Delivery SystemMRN · Traditional Linde Gas & Equipment, Inc.05/23/2024SE
K222930Evolve Nitric Oxide Delivery SystemMRN · Traditional Mallinckrodt Manufacturing, LLC12/06/2023SE
K231823NOxBOXi Nitric Oxide Delivery SystemMRN · Special Linde Gas & Equipment, Inc.08/11/2023SE
K212409Ulspira TS Nitric Oxide Therapy SystemMRN · Traditional Airgas Therapeutics06/30/2023SE
K211153Inomax DSIRMRN · Traditional Mallinckrodt Manufacturing, LLC04/20/2023SE
K220898NOxBOXi Nitric Oxide Delivery SystemMRN · Special Linde Gas & Equipment, Inc.04/27/2022SE
K201339The NOxBOXi Nitric Oxide Delivery SystemMRN · Special Praxair, Inc.06/19/2020SE
K200389INOmax DSIR PlusMRN · Special Mallinckrodt Manufacturing, LLC06/17/2020SE

More from Mallinckrodt Manufacturing, LLC

510(k)DeviceDecision
K222930Evolve Nitric Oxide Delivery SystemMRN · Traditional 12/06/2023SE
K211153Inomax DSIRMRN · Traditional 04/20/2023SE
K200389INOmax DSIR PlusMRN · Special 06/17/2020SE

Questions and answers

When was EVOLVE Nitric Oxide Delivery System cleared by the FDA?

EVOLVE Nitric Oxide Delivery System (K242578) received a 510(k) decision of Substantially Equivalent on January 3, 2025, 127 days after the submission was received.

What is the product code of K242578?

The FDA product code is MRN – Apparatus, Nitric Oxide Delivery, a Class II (moderate risk) device regulated under 21 CFR 868.5165.