KGB · Mask, Oxygen, Non-Rebreathing
Anesthesiology · 21 CFR 868.5570 · Class 1
Overview
| Product Code | KGB |
|---|---|
| Device Name | Mask, Oxygen, Non-Rebreathing |
| Regulation | 21 CFR 868.5570 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K970688 | POCKET RESCUE | Cheen Houng Ent. Co. , Ltd. | Sep 26, 1997 | SESE |
| K960401 | ULTIMATE SEAL | Hans Rudolph, Inc. | Jun 20, 1996 | SESE |
| K941336 | COMBO MASK | Gam Industries, Inc. | Sep 9, 1994 | SESE |
| K935917 | CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES | Bd Becton Dickinson Vacutainer Systems Preanalytic | Feb 4, 1994 | SESE |
| K932347 | COMPACT MASK | Vital Signs, Inc. | Jan 10, 1994 | SESE |
| K933583 | NONREBREATHING VALVE | Hans Rudolph, Inc. | Jan 3, 1994 | SESE |
| K933048 | LAERDAL(TM) POCKET MASK, MODIFICATION | Laerdal Medical Corp. | Dec 2, 1993 | SESE |
| K930336 | PROFAST(R)-DENTURE ADHESIVE CREAM | Fittydent-Altwirth & Schmitt GmbH | Aug 24, 1993 | SESE |
| K913164 | NON REBREATHING MASK | Specialty Packaging Producs, Inc. | Jan 15, 1992 | SESE |
| K883766 | MOUTH-TO-MASK VENTILATORY ADJUNCT | Medic One | Oct 21, 1988 | SESE |
| K790162 | OXYGEN MASK, CONCENTRATION AEROSOL MASK | Airlife, Inc. | Apr 20, 1979 | SESE |
| K790161 | OXYGEN MASK W/RESERVOIR BAG | Airlife, Inc. | Apr 20, 1979 | SESE |
| K781414 | MASK, OXYGEN, NONBREATHING | Vitalab Products Corp. | Sep 7, 1978 | SESE |
Top Applicants
- Airlife, Inc. — 2 clearances
- Hans Rudolph, Inc. — 2 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Cheen Houng Ent. Co. , Ltd. — 1 clearance
- Fittydent-Altwirth & Schmitt GmbH — 1 clearance
