MRN · Class II · 21 CFR 868.5165

FDA Product Code MRN: Apparatus, Nitric Oxide Delivery

Leading manufacturers include Mallinckrodt Manufacturing, LLC, Linde Gas & Equipment, Inc. and Malinckrodt Manufacturing, LLC.

33
Total
32
Cleared
169d
Avg days
2000
Since
Declining activity - 2 submissions in the last 2 years vs 6 in the prior period
Review times improving: avg 144d recently vs 171d historically

FDA 510(k) Cleared Apparatus, Nitric Oxide Delivery Devices (Product Code MRN)

33 devices
1–24 of 33
Cleared Jan 17, 2025
ULSPIRA TS™ Nitric Oxide Therapy System
K242374
Airgas Therapeutics, LLC
Anesthesiology · 161d
Cleared Jan 03, 2025
EVOLVE Nitric Oxide Delivery System
K242578
Mallinckrodt Manufacturing, LLC
Anesthesiology · 127d
Cleared May 28, 2024
EVOLVE Nitric Oxide Delivery System
K240410
Malinckrodt Manufacturing, LLC
Anesthesiology · 106d
Cleared May 23, 2024
NOxBOXi Nitric Oxide Delivery System
K233251
Linde Gas & Equipment, Inc.
Anesthesiology · 238d
Cleared Dec 06, 2023
Evolve Nitric Oxide Delivery System
K222930
Mallinckrodt Manufacturing, LLC
Anesthesiology · 436d
Cleared Aug 11, 2023
NOxBOXi Nitric Oxide Delivery System
K231823
Linde Gas & Equipment, Inc.
Anesthesiology · 51d
Cleared Jun 30, 2023
Ulspira TS Nitric Oxide Therapy System
K212409
Airgas Therapeutics
Anesthesiology · 696d
Cleared Apr 20, 2023
Inomax DSIR
K211153
Mallinckrodt Manufacturing, LLC
Anesthesiology · 731d
Cleared Apr 27, 2022
NOxBOXi Nitric Oxide Delivery System
K220898
Linde Gas & Equipment, Inc.
Anesthesiology · 30d
Cleared Jun 19, 2020
The NOxBOXi Nitric Oxide Delivery System
K201339
Praxair, Inc.
Anesthesiology · 30d
Cleared Jun 17, 2020
INOmax DSIR Plus
K200389
Mallinckrodt Manufacturing, LLC
Anesthesiology · 120d
Cleared Mar 10, 2020
AeroNOx 2.0 Nitric Oxide Titration & Monitoring System
K193481
International Biomedical
Anesthesiology · 84d
Cleared Oct 02, 2018
NOxBOXi Nitric Oxide Delivery System
K171696
Praxair Distribution, Inc.
Anesthesiology · 482d

About Product Code MRN - Regulatory Context

510(k) Submission Activity

33 total 510(k) submissions under product code MRN since 2000, with 32 receiving FDA clearance (average review time: 169 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 6 in the prior period.

FDA 510(k) Review Time - MRN Product Code

Recent submissions under MRN have taken an average of 144 days to reach a decision - down from 171 days historically, suggesting improved FDA processing for this classification.

MRN devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →