BYJ · Unit, Liquid-Oxygen, Portable
Anesthesiology · 21 CFR 868.5655 · Class 2
Overview
| Product Code | BYJ |
|---|---|
| Device Name | Unit, Liquid-Oxygen, Portable |
| Regulation | 21 CFR 868.5655 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 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 | DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) | Essex Industries, Inc. D/B/A Essex Cryogenics of M | Jul 19, 2013 | SESE |
| K113767 | MOUNTED MEDICAL OXYGEN SYSTEM | Essex Industries, Inc. | Jun 29, 2012 | SESE |
| K103324 | PRECISION LIQUID OXYGEN SYSTEM | Precision Medical, Inc. | Apr 21, 2011 | SESE |
| K101272 | MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 | Essex Industries, Inc. | Aug 20, 2010 | SESE |
| K081779 | GOLOX-93 | Respironics, Inc. | Sep 19, 2008 | SESE |
| K080023 | MODIFICATION TO: SPIRIT | Caire, Inc. | Jun 16, 2008 | SESE |
| K072723 | RESPIRONICS GOLOX | Respironics, Inc. | Mar 20, 2008 | SESE |
| K072011 | COPD LIQUID OXYGEN PORTABLE, MODEL 300P | Copd Partners, Inc. | Oct 18, 2007 | SESE |
| K071581 | BACKPACK MEDICAL OXYGEN SYSTEM | Essex Cryogenics of Missouri, Inc. | Jul 11, 2007 | SESE |
| K050153 | SPIRIT, MODEL HAS | Caire, Inc. | Apr 15, 2005 | SESE |
| K050414 | PLIX | Respironics, Inc. | Apr 11, 2005 | SESE |
| K041122 | PRECISION LIQUID OXYGEN SYSTEM | Precision Medical, Inc. | Oct 4, 2004 | SESE |
| K032143 | LIQUID OXYGEN SYSTEM | Micro Technology Services, Inc. | Mar 30, 2004 | SESE |
| K033000 | NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM | Essex Cryogenics of Missouri, Inc. | Mar 22, 2004 | SESE |
| K013251 | SPIRIT 300 | Caire, Inc. | Dec 18, 2001 | SESE |
| K993220 | PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM | Puritan Bennett Corp. | Oct 22, 1999 | SESE |
| K971545 | PROTEGE LIQUID OXYGEN SYSTEM | Healthdyne Technologies, Inc. | Jul 25, 1997 | SESE |
| K963956 | PORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNIT | Southern Research, Inc. | Dec 9, 1996 | SESE |
| K941819 | LIQUID OXYGEN STORAGE SUBSYSTEM | Hogan & Hartson | May 23, 1994 | SESE |
| K933930 | 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
