510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MRNClass II

Apparatus, Nitric Oxide Delivery

21 CFR 868.5165 / Anesthesiology
FDA source (opens on fda.gov)

MRN is the FDA product code for Apparatus, Nitric Oxide Delivery, a class II device type, regulated under 21 CFR 868.5165. As of , FDA records hold 33 510(k) clearances under this code, the most recent dated , and 16 recalls.

Classification record

Product code
MRN
Device name
Apparatus, Nitric Oxide Delivery
Regulation
21 CFR 868.5165
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
33
Ingested recalls
18

Clearances, product code MRN

By decision year
33 clearances under product code MRN with a decision year between 2000 and 2025, 2023 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code MRN by decision year
YearClearances
20003
20041
20061
20072
20082
20091
20102
20112
20123
20132
20151
20181
20203
20221
20234
20242
20252

Applicants with the most clearances

Product code MRN
Applicants holding the most 510(k) clearances under product code MRN
ApplicantClearances
Mallinckrodt Manufacturing LLC16
Linde Gas & Equipment Inc.3
Airgas Therapeutics LLC2
GE Healthcare2
Ino Therapeutics/Ikaria2
International Biomedical, Ltd.2
Pulmonox Medical, Inc.2
Geno, LLC1
Malinckrodt Manufacturing, LLC1
Praxair Distribution, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code