Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart C — Monitoring Devices](/submissions/AN/subpart-c%E2%80%94monitoring-devices) → [21 CFR 868.2700](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2700) → CAN — Regulator, Pressure, Gas Cylinder # CAN · Regulator, Pressure, Gas Cylinder _Anesthesiology · 21 CFR 868.2700 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN ## Overview - **Product Code:** CAN - **Device Name:** Regulator, Pressure, Gas Cylinder - **Regulation:** [21 CFR 868.2700](/submissions/AN/subpart-c%E2%80%94monitoring-devices/868.2700) - **Device Class:** 1 - **Review Panel:** [Anesthesiology](/submissions/AN) ## 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](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K162811.md) | MR Conditional CGA 870 | Essex Industries, Inc. | Mar 2, 2017 | SESE | | [K080243](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K080243.md) | PORTABLE OXYGEN UNIT SCA900 | San Cheong Co. , Ltd. | Apr 7, 2009 | SESE | | [K060265](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K060265.md) | REMCORE REMOTE CONTROLLED OXYGEN REGULATOR | Remcore, Inc. | Oct 25, 2006 | SESE | | [K061785](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K061785.md) | CYL-FIL OXYGEN SYSTEM | Responsive Respiratory, Inc. | Sep 7, 2006 | SESE | | [K950777](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K950777.md) | OXYGEN REGULATOR | Mada Medical Products, Inc. | Apr 14, 1995 | SESE | | [K942751](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K942751.md) | VANGUARD SERIES GAS REGULATORS | Buckman Co., Inc. | Feb 9, 1995 | SESE | | [K936187](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K936187.md) | LSPI PRESSURE REGULATOR | Life Support Products, Inc. | Jan 27, 1994 | SESE | | [K932006](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K932006.md) | 1500 SERIES REGULATOR | Precision Medical, Inc. | Oct 25, 1993 | SESE | | [K921125](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K921125.md) | AMBU OXYGEN REGULATOR | Amg, LLC | Sep 17, 1992 | SESE | | [K915154](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K915154.md) | GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS | C.G.H. Medical, Inc. | May 27, 1992 | SESE | | [K915505](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K915505.md) | REGULATOR FLOWMETER | Lifeguard Medical Products, Inc. | Apr 22, 1992 | SESE | | [K914271](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K914271.md) | GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) | C.G.H. Medical, Inc. | Apr 13, 1992 | SESE | | [K912174](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K912174.md) | SALTER LABS DISPOSABLE NIPPLE AND NUT | Salter Labs | Jul 24, 1991 | SESE | | [K901831](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K901831.md) | PRECISION MEDICAL OXYGEN REGULATOR | Precision Medical, Inc. | Aug 14, 1990 | SESE | | [K901623](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K901623.md) | AMBU OXYGEN REGULATOR | Flotec, Inc. | Apr 26, 1990 | SESE | | [K895956](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K895956.md) | RX02 EMERGENCY MEDICAL OXYGEN | Progressive Medical Applications Corp. | Apr 5, 1990 | SESE | | [K900115](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K900115.md) | VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B | Ventlab Corp. | Feb 22, 1990 | SESE | | [K896152](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K896152.md) | PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW. | Puritan Bennett Corp. | Jan 9, 1990 | SESE | | [K896128](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K896128.md) | PURITAN-BENNETT OXYGEN PRESSURE REGULATOR | Puritan Bennett Corp. | Jan 9, 1990 | SESE | | [K894850](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN/K894850.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/CAN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com