Product code CAN
- Device name
- Regulator, Pressure, Gas Cylinder
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.2700
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162811 | MR Conditional CGA 870 | Essex Industries, Inc. | 2017-03-02 |
| K080243 | PORTABLE OXYGEN UNIT SCA900 | San Cheong Co. , Ltd. | 2009-04-07 |
| K060265 | REMCORE REMOTE CONTROLLED OXYGEN REGULATOR | Remcore, Inc. | 2006-10-25 |
| K061785 | CYL-FIL OXYGEN SYSTEM | Responsive Respiratory, Inc. | 2006-09-07 |
| K950777 | OXYGEN REGULATOR | Mada Medical Products, Inc. | 1995-04-14 |
| K942751 | VANGUARD SERIES GAS REGULATORS | Buckman Co., Inc. | 1995-02-09 |
| K936187 | LSPI PRESSURE REGULATOR | Life Support Products, Inc. | 1994-01-27 |
| K932006 | 1500 SERIES REGULATOR | Precision Medical, Inc. | 1993-10-25 |
| K921125 | AMBU OXYGEN REGULATOR | Amg, LLC | 1992-09-17 |
| K915154 | GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS | C.G.H. Medical, Inc. | 1992-05-27 |
| K915505 | REGULATOR FLOWMETER | Lifeguard Medical Products, Inc. | 1992-04-22 |
| K914271 | GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) | C.G.H. Medical, Inc. | 1992-04-13 |
| K912174 | SALTER LABS DISPOSABLE NIPPLE AND NUT | Salter Labs | 1991-07-24 |
| K901831 | PRECISION MEDICAL OXYGEN REGULATOR | Precision Medical, Inc. | 1990-08-14 |
| K901623 | AMBU OXYGEN REGULATOR | Flotec, Inc. | 1990-04-26 |
| K895956 | RX02 EMERGENCY MEDICAL OXYGEN | Progressive Medical Applications Corp. | 1990-04-05 |
| K900115 | VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B | Ventlab Corp. | 1990-02-22 |
| K896128 | PURITAN-BENNETT OXYGEN PRESSURE REGULATOR | Puritan Bennett Corp. | 1990-01-09 |
| K896152 | PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW. | Puritan Bennett Corp. | 1990-01-09 |
| K894850 | 8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI | Modern Engineering Co., Inc. | 1989-08-31 |
| K894302 | OXYGEN THERAPY REGULATOR | Modern Engineering Co., Inc. | 1989-08-07 |
| K893621 | CONCOA PRESSURE REGULATORS | Concoa Controls Corp. of America | 1989-07-28 |
| K884927 | BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER | Instrumentation Industries, Inc. | 1989-06-23 |
| K891771 | VICTOR MEDICAL OXYGEN THERAPY REGULATOR, MODIFIED | Thermadyne Holings Corp. | 1989-06-23 |
| K883483 | AUTOFLOW PART NUMBER PR3241-420 PRESSURE REGULATOR | Autoflow Products, Co. | 1988-10-07 |
| K872170 | CRT PORTABLE EMERGENCY OXYGEN INHALATOR | Cost Reduction Technologies, Inc. | 1987-09-03 |
| K865077 | ACCU-FLO REGULATOR | Alum-Ox, Inc. | 1987-02-10 |
| K863711 | REGULATOR OXYGEN MECHANICAL | Lifeguard Medical Products, Inc. | 1987-01-27 |
| K862796 | AIRCO PRESSURE REGULATORS | Airco, Inc. | 1986-08-08 |
| K862193 | # 10099/10225/10235/10275/10525/10625/10715/10125 | U.O. Equipment Co. | 1986-07-09 |
Related GUDID Devices#
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|---|---|---|---|
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| 00848530108120 | Regulator | Sunset Healthcare Solutions, Inc. | 2026-01-26 |
| 00848530107765 | Repair Parts | Sunset Healthcare Solutions, Inc. | 2025-11-24 |
| 00848530107413 | React Regulator Valve | Sunset Healthcare Solutions, Inc. | 2025-09-17 |
| 00848530106041 | Oxygen Accessory | Sunset Healthcare Solutions, Inc. | 2025-06-03 |
| 00848530106034 | Oxygen Accessory | Sunset Healthcare Solutions, Inc. | 2025-06-03 |
| 00848530086220 | Suction Canister Supplies | Sunset Healthcare Solutions, Inc. | 2024-07-31 |
| 00848530092122 | Regulators/Conservers | Sunset Healthcare Solutions, Inc. | 2024-06-27 |
| 00848530092504 | Regulators/Conservers | Sunset Healthcare Solutions, Inc. | 2024-06-27 |
| 00848530092498 | Regulators/Conservers | Sunset Healthcare Solutions, Inc. | 2024-06-27 |
| 00848530092139 | Regulators/Conservers | Sunset Healthcare Solutions, Inc. | 2024-06-27 |
| 00848530092115 | Regulators/Conservers | Sunset Healthcare Solutions, Inc. | 2024-06-27 |
| 00848530060664 | Regulators/Conservers | Sunset Healthcare Solutions, Inc. | 2024-06-27 |
| 00848530060688 | Regulators/Conservers | Sunset Healthcare Solutions, Inc. | 2024-06-27 |
| 00848530060695 | Regulators/Conservers | Sunset Healthcare Solutions, Inc. | 2024-06-27 |
| 00848530100605 | Regulators/Conservers | Sunset Healthcare Solutions, Inc. | 2024-06-24 |
| 00848530087777 | Personal Device Holder | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530100117 | CPAP Accessory | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530093754 | Personal Device Holder | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530101886 | Respiratory Accessory | Sunset Healthcare Solutions, Inc. | 2024-06-06 |
| 00848530100469 | Oxygen Regulator | Sunset Healthcare Solutions, Inc. | 2024-06-03 |
| 00848530081027 | Mini CGA 540 Style Regulator 0-4lpm Pediatric (0, 1/32, 1/16, 1/8, 1/4, 1/2, 3/4 | Sunset Healthcare Solutions, Inc. | 2018-09-21 |
| 00848530081034 | Mini CGA 870 Style Regulator 0-8lpm (no gauge) | Sunset Healthcare Solutions, Inc. | 2018-09-21 |
| 00848530060718 | Mini CGA 540 style O2 Regulator; 0-15 LPM | Sunset Healthcare Solutions, Inc. | 2018-09-21 |
| 00848530081041 | CGA 870 Style Regulator 0-15lpm (no gauge) | Sunset Healthcare Solutions, Inc. | 2018-09-21 |
| 00848530060671 | Mini CGA 870 style regulator; 0-15 lpm | Sunset Healthcare Solutions, Inc. | 2018-09-21 |
| 00848530087470 | Extended CGA 540 Style Regulator, 0-15 LPM, with Long Stem | Sunset Healthcare Solutions, Inc. | 2018-09-21 |
| 00848530081010 | Mini CGA 870 Style Regulator 0-4lpm Pediatric | Sunset Healthcare Solutions, Inc. | 2018-09-17 |
| 00848530060701 | Mini CGA 540 Style Regulator- 0-8 lpm | Sunset Healthcare Solutions, Inc. | 2018-09-17 |
| 00848530060657 | Mini CGA 870 style regulator 0-8 lpm | Sunset Healthcare Solutions, Inc. | 2018-09-17 |