Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5655](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5655) → BYJ — Unit, Liquid-Oxygen, Portable # BYJ · Unit, Liquid-Oxygen, Portable _Anesthesiology · 21 CFR 868.5655 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ ## Overview - **Product Code:** BYJ - **Device Name:** Unit, Liquid-Oxygen, Portable - **Regulation:** [21 CFR 868.5655](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5655) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **3rd-party reviewable:** yes ## Identification A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 55) Showing 20 most recent of 55 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K130068](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K130068.md) | DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) | Essex Industries, Inc. D/B/A Essex Cryogenics of M | Jul 19, 2013 | SESE | | [K113767](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K113767.md) | MOUNTED MEDICAL OXYGEN SYSTEM | Essex Industries, Inc. | Jun 29, 2012 | SESE | | [K103324](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K103324.md) | PRECISION LIQUID OXYGEN SYSTEM | Precision Medical, Inc. | Apr 21, 2011 | SESE | | [K101272](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K101272.md) | MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 | Essex Industries, Inc. | Aug 20, 2010 | SESE | | [K081779](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K081779.md) | GOLOX-93 | Respironics, Inc. | Sep 19, 2008 | SESE | | [K080023](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K080023.md) | MODIFICATION TO: SPIRIT | Caire, Inc. | Jun 16, 2008 | SESE | | [K072723](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K072723.md) | RESPIRONICS GOLOX | Respironics, Inc. | Mar 20, 2008 | SESE | | [K072011](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K072011.md) | COPD LIQUID OXYGEN PORTABLE, MODEL 300P | Copd Partners, Inc. | Oct 18, 2007 | SESE | | [K071581](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K071581.md) | BACKPACK MEDICAL OXYGEN SYSTEM | Essex Cryogenics of Missouri, Inc. | Jul 11, 2007 | SESE | | [K050153](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K050153.md) | SPIRIT, MODEL HAS | Caire, Inc. | Apr 15, 2005 | SESE | | [K050414](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K050414.md) | PLIX | Respironics, Inc. | Apr 11, 2005 | SESE | | [K041122](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K041122.md) | PRECISION LIQUID OXYGEN SYSTEM | Precision Medical, Inc. | Oct 4, 2004 | SESE | | [K032143](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K032143.md) | LIQUID OXYGEN SYSTEM | Micro Technology Services, Inc. | Mar 30, 2004 | SESE | | [K033000](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K033000.md) | NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM | Essex Cryogenics of Missouri, Inc. | Mar 22, 2004 | SESE | | [K013251](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K013251.md) | SPIRIT 300 | Caire, Inc. | Dec 18, 2001 | SESE | | [K993220](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K993220.md) | PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM | Puritan Bennett Corp. | Oct 22, 1999 | SESE | | [K971545](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K971545.md) | PROTEGE LIQUID OXYGEN SYSTEM | Healthdyne Technologies, Inc. | Jul 25, 1997 | SESE | | [K963956](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K963956.md) | PORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNIT | Southern Research, Inc. | Dec 9, 1996 | SESE | | [K941819](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K941819.md) | LIQUID OXYGEN STORAGE SUBSYSTEM | Hogan & Hartson | May 23, 1994 | SESE | | [K933930](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ/K933930.md) | PURITAN-BENNETT COMPANION 550 LIQUID OXYGEN PORTABLE UNIT | Puritan Bennett Corp. | Mar 21, 1994 | SESE | ## Top Applicants - Puritan Bennett Corp. — 7 clearances - Union Carbide Corp. — 5 clearances - Minnesota Valley Engineering, Inc. — 4 clearances - Caire, Inc. — 3 clearances - Essex Cryogenics of Missouri, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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