DeviceClearance

Product code MRN— Anesthesiology

NOxBOXi Nitric Oxide Delivery System

Classification name
Apparatus, Nitric Oxide Delivery
Device class
Class 2
Regulation
21 CFR 868.5165
Advisory panel
Anesthesiology
Total cleared
33
First cleared
Most recent

Market context for product code MRN

FDA has cleared 33 devices under product code MRN between 2000 and 2025, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code MRN

Adverse events under product code MRN

product code MRN
Death
9
Malfunction
910
Total
919

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code MRN

Data sourced from openFDA. This site is unofficial and independent of the FDA.