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).
Cleared Devices (55)
| 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 |
| K926267 | MOBILAIRE LIQUID OXYGEN SYSTEMS | Invacare Corp. | Aug 31, 1993 | SESE |
| K903140 | PURITAN-BENNETT COMPAN EMT W/REMOTE LIQ LEV GUAGE | Puritan Bennett Corp. | Sep 5, 1990 | SESE |
| K895387 | PURITAN-BENNETT COMPANION EMT LIQUID OXYGEN | Puritan Bennett Corp. | Jan 24, 1990 | SESE |
| K895082 | VOYAGER PX | Smith-Perry Corp. | Jan 9, 1990 | SESE |
| K882328 | HI FLOW 50 | Minnesota Valley Engineering, Inc. | Jun 28, 1988 | SESE |
| K880183 | PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT | Essex Cryogenics of Missouri, Inc. | Apr 14, 1988 | SESE |
| K880101 | LIBERATOR 53/STROLLER 50 | Minnesota Valley Engineering, Inc. | Feb 29, 1988 | SESE |
| K875352 | HI FLOW PORTABLE LIQUID OXYGEN UNIT | Minnesota Valley Engineering, Inc. | Feb 29, 1988 | SESE |
| K872449 | NOMAD (BASE UNIT/PORTABLE UNIT) | Minnesota Valley Engineering, Inc. | Jul 21, 1987 | SESE |
| K864280 | ECONOL (PORTABLE) ECONO 30 & 40 LITER BASE UNIT | Smith-Taylor Mfg. Co., Div. Allied Medical Corp. | Jan 28, 1987 | SESE |
| K863978 | PORTABLE LIQUID OXYGEN UNIT (MODIFICATION) | Penox Technologies, Inc. | Dec 15, 1986 | SESE |
| K863556 | CSI LIQUID OXYGEN SYSTEM | Cryogenic Services, Inc. | Oct 15, 1986 | SESE |
| K863205 | SWIVEL COUPLER | Venmill Swivel, Co. | Oct 2, 1986 | SESE |
| K860738 | CTC 30, 40, 1 LIQUID OXYGEN LITERS | Cryodyne Technologies, Inc. | Aug 6, 1986 | SESE |
| K861503 | COMPANION LIQUID OXYGEN SYSTEM | Puritan Bennett Corp. | Jun 25, 1986 | SESE |
| K860937 | MARK 4 LIQUID OXYGEN SYSTEM | Puritan Bennett Corp. | Mar 20, 1986 | SESE |
| K853775 | PENOX HIGH FLOW MANIFOLD | Penox Technologies, Inc. | Nov 29, 1985 | SESE |
| K853083 | RESERVIOR-MASTERAIR PORTABLE-FREEDOMAIR | Home Medical Supply, Inc. | Sep 3, 1985 | SESE |
| K841808 | STROLLER SPRINT | Cryogenic Assoc. | May 16, 1984 | SESE |
| K840534 | LIQUID OXYGEN SYSTEM | The John Bunn Co. | Mar 2, 1984 | SESE |
| K834290 | INSPIRON LIQUID OXYGEN SYSTEM | Inspiron Corp. | Feb 4, 1984 | SESE |
| K833994 | PULSAIR I & II | Cryo Corp. | Dec 12, 1983 | SESE |
| K832143 | MARK III OXYGEN WALKER SYS. RESERVOIR | Linde Div. Union Carbide Corp. | Aug 26, 1983 | SESE |
| K830337 | MARK III OXYGEN WALKER SYS-LOW PRESS | Union Carbide Corp. | Mar 17, 1983 | SESE |
| K830498 | LIQUID OXYGEN SYSTEM | Puritan Bennett Corp. | Mar 10, 1983 | SESE |
| K820836 | MARK III OXYGEN WALKER SYSTEM | Union Carbide Corp. | Apr 15, 1982 | SESE |
| K813453 | UNIT, LIQUID, OXYGEN, PORTABLE | Pensee Medical Corp. | Jan 12, 1982 | SESE |
| K812536 | LINDE MARK II | Union Carbide Corp. | Sep 23, 1981 | SESE |
| K811162 | FLOWLOCK OXYGEN METER | Lifeguard Medical Products, Inc. | May 8, 1981 | SESE |
| K810732 | LINDE MARK II OXYGEN RESERV. TYPE OR-4 | Union Carbide Corp. | Mar 27, 1981 | SESE |
| K800742 | LIBERATOR/STROLLER II SYSTEM | Cryogenic Assoc. | May 23, 1980 | SESE |
| K791902 | LINDE OXYGEN WALKER SYS. MARK II-L | Union Carbide Corp. | Oct 17, 1979 | SESE |
| K780496 | TRAVELAIR AND STATIONAIR | Cryomed Corp. | Apr 18, 1978 | SESE |
| K780098 | LIQUID OXYGEN UNIT, PORTABLE 73BYJ | Andonian Cryogenics, Inc. | Mar 2, 1978 | SESE |
| K760787 | LIBERATOR/STROLLER | Burditt & Calkins-Siemens-Elema | Oct 22, 1976 | SESE |
Top Applicants
- Puritan Bennett Corp. — 7 clearances
- Union Carbide Corp. — 5 clearances
- Minnesota Valley Engineering, Inc. — 4 clearances
- Respironics, Inc. — 3 clearances
- Essex Cryogenics of Missouri, Inc. — 3 clearances
