FDA product code MRP: Analyzer, Nitric Oxide
MRP is the FDA product code for analyzer, nitric oxide. It is a Class II device, regulated under 21 CFR 868.2380 and reviewed by the Anesthesiology panel. FDA has cleared 1 510(k) submission under MRP. The average 510(k) review took 338 days (median 338).
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Nitric Oxide |
| Device class | Class II |
| Regulation | 21 CFR 868.2380 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every MRP clearance
Top MRP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pulmonox Medical, Inc. | 1 | 2003-08-14 |
Most recent MRP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023014 | Pulmonox Medical, Inc. | VIANOX DELIVERY SYSTEM, MODEL I | 2003-08-14 | 338 |
Recalls for MRP devices
openFDA lists no recalls for product code MRP.
Frequently asked questions
What is FDA product code MRP?
MRP is the FDA product code for analyzer, nitric oxide. It is a Class II device, regulated under 21 CFR 868.2380 and reviewed by the Anesthesiology panel.
What device class is MRP?
Class II, regulation 21 CFR 868.2380. Typical premarket route: 510(k).
How long does a 510(k) take for product code MRP?
Across 1 cleared submissions the average was 338 days from receipt to decision (median 338).
Which companies have the most MRP clearances?
Pulmonox Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MRP
- Run a recall and safety report across every MRP manufacturer
- Watch product code MRP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Anesthesiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times