Unit, Liquid-Oxygen, Portable
FDA product code BYJ · Class II (moderate risk) · 21 CFR 868.5655 · Anesthesiology
55510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Puritan Bennett Corp. 7
- Union Carbide Corp. 5
- Minnesota Valley Engineering, Inc. 4
- Caire, Inc. 3
- Essex Cryogenics of Missouri, Inc. 3
- Respironics, Inc. 3
- Cryogenic Assoc. 2
- Precision Medical, Inc. 2
- Essex Industries, Inc. 2
- Penox Technologies, Inc. 2
- Inspiron Corp. 1
- Cryogenic Services, Inc. 1
- Cryodyne Technologies, Inc. 1
- Home Medical Supply, Inc. 1
- The John Bunn Co. 1
- Essex Industries, Inc. D/B/A Essex Cryogenics of M 1
- Linde Div. Union Carbide Corp. 1
- Pensee Medical Corp. 1
- Lifeguard Medical Products, Inc. 1
- Cryomed Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K130068 | Dismounted Medical & Supplemental Oxygen System (Dmos)BYJ · Traditional | Essex Industries, Inc. D/B/A Essex Cryogenics of M | 07/19/2013SE |
| K113767 | Mounted Medical Oxygen SystemBYJ · Traditional | Essex Industries, Inc. | 06/29/2012SE |
| K103324 | Precision Liquid Oxygen SystemBYJ · Traditional | Precision Medical, Inc. | 04/21/2011SE |
| K101272 | Mass Oxygen Distribution System (Mods) Model 10C-0061-3BYJ · Traditional | Essex Industries, Inc. | 08/20/2010SE |
| K081779 | GOLOX-93BYJ · Traditional | Respironics, Inc. | 09/19/2008SE |
| K080023 | Modification to: SpiritBYJ · Special | Caire, Inc. | 06/16/2008SE |
| K072723 | Respironics GoloxBYJ · Traditional | Respironics, Inc. | 03/20/2008SE |
| K072011 | Copd Liquid Oxygen Portable, Model 300PBYJ · Traditional | Copd Partners, Inc. | 10/18/2007SE |
| K071581 | Backpack Medical Oxygen SystemBYJ · Traditional | Essex Cryogenics of Missouri, Inc. | 07/11/2007SE |
| K050153 | Spirit, Model HasBYJ · Traditional | Caire, Inc. | 04/15/2005SE |
| K050414 | PlixBYJ · Traditional | Respironics, Inc. | 04/11/2005SE |
| K041122 | Precision Liquid Oxygen SystemBYJ · Traditional | Precision Medical, Inc. | 10/04/2004SE |
| K032143 | Liquid Oxygen SystemBYJ · Traditional | Micro Technology Services, Inc. | 03/30/2004SE |
| K033000 | Next Generation Portable Therapeutic Liquid Oxygen SystemBYJ · Traditional | Essex Cryogenics of Missouri, Inc. | 03/22/2004SE |
| K013251 | Spirit 300BYJ · Traditional | Caire, Inc. | 12/18/2001SE |
| K993220 | Puritan-Bennett Helios Portable Liquid Oxygen SystemBYJ · Special | Puritan Bennett Corp. | 10/22/1999SE |
| K971545 | Protege Liquid Oxygen SystemBYJ · Traditional | Healthdyne Technologies, Inc. | 07/25/1997SE |
| K963956 | Portable Liquid Oxygen Unit and Stationary Liquid Oxygen UnitBYJ · Traditional | Southern Research, Inc. | 12/09/1996SE |
| K941819 | Liquid Oxygen Storage SubsystemBYJ · Traditional | Hogan & Hartson | 05/23/1994SE |
| K933930 | Puritan-Bennett Companion 550 Liquid Oxygen Portable UnitBYJ · Traditional | Puritan Bennett Corp. | 03/21/1994SE |
| K926267 | Mobilaire Liquid Oxygen SystemsBYJ · Traditional | Invacare Corp. | 08/31/1993SE |
| K903140 | Puritan-Bennett Compan Emt W/Remote Liq Lev GuageBYJ · Traditional | Puritan Bennett Corp. | 09/05/1990SE |
| K895387 | Puritan-Bennett Companion Emt Liquid OxygenBYJ · Traditional | Puritan Bennett Corp. | 01/24/1990SE |
| K895082 | Voyager PXBYJ · Traditional | Smith-Perry Corp. | 01/09/1990SE |
| K882328 | Hi Flow 50BYJ · Traditional | Minnesota Valley Engineering, Inc. | 06/28/1988SE |
| K880183 | Portable Therapeutic Liquid Oxygen UnitBYJ · Traditional | Essex Cryogenics of Missouri, Inc. | 04/14/1988SE |
| K880101 | Liberator 53/STROLLER 50BYJ · Traditional | Minnesota Valley Engineering, Inc. | 02/29/1988SE |
| K875352 | Hi Flow Portable Liquid Oxygen UnitBYJ · Traditional | Minnesota Valley Engineering, Inc. | 02/29/1988SE |
| K872449 | Nomad (Base Unit/Portable Unit)BYJ · Traditional | Minnesota Valley Engineering, Inc. | 07/21/1987SE |
| K864280 | Econol (Portable) Econo 30 & 40 Liter Base UnitBYJ · Traditional | Smith-Taylor Mfg. Co., Div. Allied Medical Corp. | 01/28/1987SE |
| K863978 | Portable Liquid Oxygen Unit (Modification)BYJ · Traditional | Penox Technologies, Inc. | 12/15/1986SE |
| K863556 | Csi Liquid Oxygen SystemBYJ · Traditional | Cryogenic Services, Inc. | 10/15/1986SE |
| K863205 | Swivel CouplerBYJ · Traditional | Venmill Swivel, Co. | 10/02/1986SE |
| K860738 | CTC 30, 40, 1 Liquid Oxygen LitersBYJ · Traditional | Cryodyne Technologies, Inc. | 08/06/1986SE |
| K861503 | Companion Liquid Oxygen SystemBYJ · Traditional | Puritan Bennett Corp. | 06/25/1986SE |
| K860937 | Mark 4 Liquid Oxygen SystemBYJ · Traditional | Puritan Bennett Corp. | 03/20/1986SE |
| K853775 | Penox High Flow ManifoldBYJ · Traditional | Penox Technologies, Inc. | 11/29/1985SE |
| K853083 | Reservior-Masterair Portable-FreedomairBYJ · Traditional | Home Medical Supply, Inc. | 09/03/1985SE |
| K841808 | Stroller SprintBYJ · Traditional | Cryogenic Assoc. | 05/16/1984SE |
| K840534 | Liquid Oxygen SystemBYJ · Traditional | The John Bunn Co. | 03/02/1984SE |
| K834290 | Inspiron Liquid Oxygen SystemBYJ · Traditional | Inspiron Corp. | 02/04/1984SE |
| K833994 | Pulsair I & IIBYJ · Traditional | Cryo Corp. | 12/12/1983SE |
| K832143 | Mark III Oxygen Walker Sys. ReservoirBYJ · Traditional | Linde Div. Union Carbide Corp. | 08/26/1983SE |
| K830337 | Mark III Oxygen Walker Sys-Low PressBYJ · Traditional | Union Carbide Corp. | 03/17/1983SE |
| K830498 | Liquid Oxygen SystemBYJ · Traditional | Puritan Bennett Corp. | 03/10/1983SE |
| K820836 | Mark III Oxygen Walker SystemBYJ · Traditional | Union Carbide Corp. | 04/15/1982SE |
| K813453 | Unit, Liquid, Oxygen, PortableBYJ · Traditional | Pensee Medical Corp. | 01/12/1982SE |
| K812536 | Linde Mark IIBYJ · Traditional | Union Carbide Corp. | 09/23/1981SE |
| K811162 | Flowlock Oxygen MeterBYJ · Traditional | Lifeguard Medical Products, Inc. | 05/08/1981SE |
| K810732 | Linde Mark II Oxygen Reserv. Type OR-4BYJ · Traditional | Union Carbide Corp. | 03/27/1981SE |
| K800742 | Liberator/Stroller II SystemBYJ · Traditional | Cryogenic Assoc. | 05/23/1980SE |
| K791902 | Linde Oxygen Walker Sys. Mark Ii-LBYJ · Traditional | Union Carbide Corp. | 10/17/1979SE |
| K780496 | Travelair and StationairBYJ · Traditional | Cryomed Corp. | 04/18/1978SE |
| K780098 | Liquid Oxygen Unit, Portable 73BYJBYJ · Traditional | Andonian Cryogenics, Inc. | 03/02/1978SE |
| K760787 | Liberator/StrollerBYJ · Traditional | Burditt & Calkins-Siemens-Elema | 10/22/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0339-2023 Class I | CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System UnitAn audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner… | Caire, Inc. | 10/10/2022Terminated |
| Z-0338-2023 Class I | CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System UnitAn audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner… | Caire, Inc. | 10/10/2022Terminated |
| Z-0337-2023 Class I | CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System UnitAn audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner… | Caire, Inc. | 10/10/2022Terminated |
| Z-0336-2023 Class I | CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System UnitAn audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner… | Caire, Inc. | 10/10/2022Terminated |
| Z-1716-2008 | Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and…Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level… | Caire, Inc. | 10/23/2007Terminated |
| Z-0153-2007 | Precision Medical- Easy Mate Portable Liquid Oxygen System (container), PM22010 Series…Component assembly; The fill chuck is not assembled properly which may allow the device to come apart over… | Precision Medical, Inc. | 10/04/2006Terminated |