FDA Product Code MRN: Apparatus, Nitric Oxide Delivery
Leading manufacturers include Mallinckrodt Manufacturing, LLC, Linde Gas & Equipment, Inc. and Malinckrodt Manufacturing, LLC.
FDA 510(k) Cleared Apparatus, Nitric Oxide Delivery Devices (Product Code MRN)
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 - 3 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under MRN have taken an average of 131 days to reach a decision - down from 173 days historically, suggesting improved FDA processing for this classification.
MRN devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →