FDA product code · Anesthesiology · Class 2
MRN: Apparatus, Nitric Oxide Delivery
MRN is FDA's product code for "Apparatus, Nitric Oxide Delivery": a Class 2 device classified under 21 CFR 868.5165, reviewed by the Anesthesiology panel. FDA flags it as life-sustaining or life-supporting.
510(k) review time for MRN
Across 13 510(k) clearances under MRN decided from 2018-01-01 to 2026-10-06, the median was 127 days from FDA receipt to decision. Half took between 84 and 436 days, and 80% were decided within 464 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 84 |
| Median | 127 |
| 75th percentile | 436 |
| 80th percentile | 464 |
| 90th percentile | 653 |
| Slowest | 731 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
MRN in the public FDA record
| 510(k) clearances, all years | 33 |
|---|---|
| Device recalls | 16 |
Counts of records, not of devices or events. Adverse event reports for MRN are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite MRN
No FDA recognized consensus standard cites MRN by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.