CAN · Regulator, Pressure, Gas Cylinder
Anesthesiology · 21 CFR 868.2700 · Class 1
Overview
| Product Code | CAN |
|---|---|
| Device Name | Regulator, Pressure, Gas Cylinder |
| Regulation | 21 CFR 868.2700 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.
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 (20 of 55)
Showing 20 most recent of 55 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K162811 | MR Conditional CGA 870 | Essex Industries, Inc. | Mar 2, 2017 | SESE |
| K080243 | PORTABLE OXYGEN UNIT SCA900 | San Cheong Co. , Ltd. | Apr 7, 2009 | SESE |
| K060265 | REMCORE REMOTE CONTROLLED OXYGEN REGULATOR | Remcore, Inc. | Oct 25, 2006 | SESE |
| K061785 | CYL-FIL OXYGEN SYSTEM | Responsive Respiratory, Inc. | Sep 7, 2006 | SESE |
| K950777 | OXYGEN REGULATOR | Mada Medical Products, Inc. | Apr 14, 1995 | SESE |
| K942751 | VANGUARD SERIES GAS REGULATORS | Buckman Co., Inc. | Feb 9, 1995 | SESE |
| K936187 | LSPI PRESSURE REGULATOR | Life Support Products, Inc. | Jan 27, 1994 | SESE |
| K932006 | 1500 SERIES REGULATOR | Precision Medical, Inc. | Oct 25, 1993 | SESE |
| K921125 | AMBU OXYGEN REGULATOR | Amg, LLC | Sep 17, 1992 | SESE |
| K915154 | GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS | C.G.H. Medical, Inc. | May 27, 1992 | SESE |
| K915505 | REGULATOR FLOWMETER | Lifeguard Medical Products, Inc. | Apr 22, 1992 | SESE |
| K914271 | GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) | C.G.H. Medical, Inc. | Apr 13, 1992 | SESE |
| K912174 | SALTER LABS DISPOSABLE NIPPLE AND NUT | Salter Labs | Jul 24, 1991 | SESE |
| K901831 | PRECISION MEDICAL OXYGEN REGULATOR | Precision Medical, Inc. | Aug 14, 1990 | SESE |
| K901623 | AMBU OXYGEN REGULATOR | Flotec, Inc. | Apr 26, 1990 | SESE |
| K895956 | RX02 EMERGENCY MEDICAL OXYGEN | Progressive Medical Applications Corp. | Apr 5, 1990 | SESE |
| K900115 | VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B | Ventlab Corp. | Feb 22, 1990 | SESE |
| K896152 | PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW. | Puritan Bennett Corp. | Jan 9, 1990 | SESE |
| K896128 | PURITAN-BENNETT OXYGEN PRESSURE REGULATOR | Puritan Bennett Corp. | Jan 9, 1990 | SESE |
| K894850 | 8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI | Modern Engineering Co., Inc. | Aug 31, 1989 | SESE |
Top Applicants
- Puritan Bennett Corp. — 3 clearances
- Airco, Inc. — 2 clearances
- C.G.H. Medical, Inc. — 2 clearances
- Instrumentation Industries, Inc. — 2 clearances
- Lifeguard Medical Products, Inc. — 2 clearances
