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.
Cleared Devices (55)
| 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 |
| K894302 | OXYGEN THERAPY REGULATOR | Modern Engineering Co., Inc. | Aug 7, 1989 | SESE |
| K893621 | CONCOA PRESSURE REGULATORS | Concoa Controls Corp. of America | Jul 28, 1989 | SESE |
| K891771 | VICTOR MEDICAL OXYGEN THERAPY REGULATOR, MODIFIED | Thermadyne Holings Corp. | Jun 23, 1989 | SESE |
| K884927 | BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER | Instrumentation Industries, Inc. | Jun 23, 1989 | SESE |
| K883483 | AUTOFLOW PART NUMBER PR3241-420 PRESSURE REGULATOR | Autoflow Products, Co. | Oct 7, 1988 | SESE |
| K872170 | CRT PORTABLE EMERGENCY OXYGEN INHALATOR | Cost Reduction Technologies, Inc. | Sep 3, 1987 | SESE |
| K865077 | ACCU-FLO REGULATOR | Alum-Ox, Inc. | Feb 10, 1987 | SESE |
| K863711 | REGULATOR OXYGEN MECHANICAL | Lifeguard Medical Products, Inc. | Jan 27, 1987 | SESE |
| K862796 | AIRCO PRESSURE REGULATORS | Airco, Inc. | Aug 8, 1986 | SESE |
| K862193 | # 10099/10225/10235/10275/10525/10625/10715/10125 | U.O. Equipment Co. | Jul 9, 1986 | SESE |
| K853039 | PRESSURE REGULATOR | Erie Medical | Apr 11, 1986 | SESE |
| K861166 | OXYGEN THERAPY REGULATOR OR REGULATOR-FLOWMETER | Victor | Apr 1, 1986 | SESE |
| K852333 | DOWNS VPAP CIRCUIT | Vital Signs, Inc. | Oct 16, 1985 | SESE |
| K852663 | PORTABLE GASEOUS OXGYEN CONTAINER | Cryogenic Assoc. | Aug 29, 1985 | SESE |
| K852649 | PRESSURE REGULATOR/Y CONNECTOR | C.R. Bard, Inc. | Aug 2, 1985 | SESE |
| K852374 | OXYGEN REGULATORS #50 PRT & BGT(BGT15,BGT18 | The Timeter Group | Jul 12, 1985 | SESE |
| K844622 | SAV-A-LIFE | Southern Medical Products, Inc. | Feb 26, 1985 | SESE |
| K850106 | AIRCO NITROUS OXIDE REGULATOR | Airco, Inc. | Jan 24, 1985 | SESE |
| K843585 | BEMCO PORTABLE OXYGEN INHALATOR | Bemco, Inc. | Oct 12, 1984 | SESE |
| K841367 | AIRCO OXYGEN REGULATOR | Welding Products | Apr 13, 1984 | SESE |
| K834061 | SLO-FLO 40AL ADJUST-FLOW REGULATOR | S.L.O. Health Products, Inc. | Jan 10, 1984 | SESE |
| K830844 | PORTABLE OXYGEN SYSTEM | Puritan Bennett Corp. | May 27, 1983 | SESE |
| K813467 | 2002 ADJUSTABLE FLOW REGULATOR | Safety Laboratories West | Jan 7, 1982 | SESE |
| K813466 | 4004 CONSTANT FLOW REGULATOR | Safety Laboratories West | Jan 7, 1982 | SESE |
| K811430 | ANESTHESIOLOGY DEVICE | Vital Air Oxygen Co. | Jun 9, 1981 | SESE |
| K810679 | MS-303-OXYGEN REGULATOR SHIELD | Instrumentation Industries, Inc. | Apr 17, 1981 | SESE |
| K810132 | MODEL 2 FLOWMETER | Harris Calorific | Jan 28, 1981 | SESE |
| K803207 | REGULATOR, OXYGEN MECHANICAL | Timeter Instrument Corp. | Jan 15, 1981 | SESE |
| K802644 | EMERG. OXYGEN KIT #65350 & #65399 CASE | B & F Medical Products, Inc. | Dec 22, 1980 | SESE |
| K780750 | O2 CONNECTOR | Diemolding Corp. | Jul 27, 1978 | SESE |
| K780359 | OXYGEN REGULATOR/FLOWMETER | Erie Mfg., Co. | Apr 4, 1978 | SESE |
| K780364 | MANIFOLD KIT | Spica, Inc. | Mar 30, 1978 | SESE |
| K780084 | OXYGEN THERAPY KIT | Thermadyne Holings Corp. | Jan 30, 1978 | SESE |
| K772216 | PORT-A-BOUT 240 | Hudson Oxygen Therapy Sales Co. | Jan 5, 1978 | SESE |
| K771241 | SPIR-E-VAC | Breathing Services, Inc. | Sep 15, 1977 | SESE |
Top Applicants
- Puritan Bennett Corp. — 3 clearances
- Thermadyne Holings Corp. — 2 clearances
- Safety Laboratories West — 2 clearances
- Precision Medical, Inc. — 2 clearances
- Modern Engineering Co., Inc. — 2 clearances
