MRO · Apparatus, Nitric Oxide, Backup Delivery
Anesthesiology · 21 CFR 868.5165 · Class 2
Overview
| Product Code | MRO |
|---|---|
| Device Name | Apparatus, Nitric Oxide, Backup Delivery |
| Regulation | 21 CFR 868.5165 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
Identification
The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.
Classification Rationale
Class II. The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”
Special Controls
The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”
The special control developed by the agency is a guidance document, entitled Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer. This guidance document identifies the risks associated with these types of devices and contains information that will help manufacturers address those risks. This document is available on FDA's website at http://www.fda.gov/cdrh/ode/1157.pdf.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K122689 | INOBLENDER | Ino Therapeutics | Nov 7, 2012 | SESE |
| K052663 | INO THERAPEUTICS INOBLENDER, MODEL 10004 | Ino Therapeutics | Nov 4, 2005 | SESE |
| K011874 | FADASIS MEDICAL FM-1 NO BLENDER | Fadasis Medical, Inc. | Jul 20, 2001 | SESE |
| K003665 | FADASSI MEDICAL FM-1 NO BLENDER | Fadasis Medical, Inc. | Feb 23, 2001 | SESE |
Top Applicants
- Fadasis Medical, Inc. — 2 clearances
- Ino Therapeutics — 2 clearances
