FDA product code MRO: Apparatus, Nitric Oxide, Backup Delivery
MRO is the FDA product code for apparatus, nitric oxide, backup delivery. It is a Class II device, regulated under 21 CFR 868.5165 and reviewed by the Anesthesiology panel. FDA has cleared 4 510(k) submissions under MRO, from 2 different applicants. The average 510(k) review took 56 days (median 51).
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Nitric Oxide, Backup Delivery |
| Device class | Class II |
| Regulation | 21 CFR 868.5165 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every MRO clearance
Top MRO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ino Therapeutics | 2 | 2012-11-07 |
| Fadasis Medical, Inc. | 2 | 2001-07-20 |
Most recent MRO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K122689 | Ino Therapeutics | INOBLENDER | 2012-11-07 | 64 |
| K052663 | Ino Therapeutics | INO THERAPEUTICS INOBLENDER, MODEL 10004 | 2005-11-04 | 38 |
| K011874 | Fadasis Medical, Inc. | FADASIS MEDICAL FM-1 NO BLENDER | 2001-07-20 | 35 |
| K003665 | Fadasis Medical, Inc. | FADASSI MEDICAL FM-1 NO BLENDER | 2001-02-23 | 87 |
Recalls for MRO devices
openFDA lists no recalls for product code MRO.
Frequently asked questions
What is FDA product code MRO?
MRO is the FDA product code for apparatus, nitric oxide, backup delivery. It is a Class II device, regulated under 21 CFR 868.5165 and reviewed by the Anesthesiology panel.
What device class is MRO?
Class II, regulation 21 CFR 868.5165. Typical premarket route: 510(k).
How long does a 510(k) take for product code MRO?
Across 4 cleared submissions the average was 56 days from receipt to decision (median 51).
Which companies have the most MRO clearances?
Ino Therapeutics (2); Fadasis Medical, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code MRO
- Run a recall and safety report across every MRO manufacturer
- Watch product code MRO 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.
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