Product Code: BYJ FDA class 2 21 CFR 868.5655

Unit, Liquid-Oxygen, Portable

Anesthesiology

The Unit, Liquid-Oxygen, Portable is a portable device that stores and delivers liquid oxygen, which is converted to gaseous oxygen as needed for patients requiring supplemental oxygen therapy outside of fixed medical facilities. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BYJ, regulated under 21 CFR 868.5655 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: BYJ
Device Class: FDA class 2
Regulation Number: 868.5655
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 55 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K130068	DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)	Jul 19, 2013	Substantially Equivalent	Essex Industries, Inc. D/B/A Essex Cryogenics of M
K113767	MOUNTED MEDICAL OXYGEN SYSTEM	Jun 29, 2012	Substantially Equivalent	Essex Industries, Inc.
K103324	PRECISION LIQUID OXYGEN SYSTEM	Apr 21, 2011	Substantially Equivalent	Precision Medical, Inc.
K101272	MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3	Aug 20, 2010	Substantially Equivalent	Essex Industries, Inc.
K081779	GOLOX-93	Sep 19, 2008	Substantially Equivalent	Respironics, Inc.
K080023	MODIFICATION TO: SPIRIT	Jun 16, 2008	Substantially Equivalent	Caire, Inc.
K072723	RESPIRONICS GOLOX	Mar 20, 2008	Substantially Equivalent	Respironics, Inc.
K072011	COPD LIQUID OXYGEN PORTABLE, MODEL 300P	Oct 18, 2007	Substantially Equivalent	Copd Partners, Inc.
K071581	BACKPACK MEDICAL OXYGEN SYSTEM	Jul 11, 2007	Substantially Equivalent	Essex Cryogenics of Missouri, Inc.
K050153	SPIRIT, MODEL HAS	Apr 15, 2005	Substantially Equivalent	Caire, Inc.
K050414	PLIX	Apr 11, 2005	Substantially Equivalent	Respironics, Inc.
K041122	PRECISION LIQUID OXYGEN SYSTEM	Oct 04, 2004	Substantially Equivalent	Precision Medical, Inc.
K032143	LIQUID OXYGEN SYSTEM	Mar 30, 2004	Substantially Equivalent	Micro Technology Services, Inc.
K033000	NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM	Mar 22, 2004	Substantially Equivalent	Essex Cryogenics of Missouri, Inc.
K013251	SPIRIT 300	Dec 18, 2001	Substantially Equivalent	Caire, Inc.
K993220	PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM	Oct 22, 1999	Substantially Equivalent	Puritan Bennett Corp.
K971545	PROTEGE LIQUID OXYGEN SYSTEM	Jul 25, 1997	Substantially Equivalent	Healthdyne Technologies, Inc.
K963956	PORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNIT	Dec 09, 1996	Substantially Equivalent	Southern Research, Inc.
K941819	LIQUID OXYGEN STORAGE SUBSYSTEM	May 23, 1994	Substantially Equivalent	Hogan & Hartson
K933930	PURITAN-BENNETT COMPANION 550 LIQUID OXYGEN PORTABLE UNIT	Mar 21, 1994	Substantially Equivalent	Puritan Bennett Corp.
K926267	MOBILAIRE LIQUID OXYGEN SYSTEMS	Aug 31, 1993	Substantially Equivalent	Invacare Corp.
K903140	PURITAN-BENNETT COMPAN EMT W/REMOTE LIQ LEV GUAGE	Sep 05, 1990	Substantially Equivalent	Puritan Bennett Corp.
K895387	PURITAN-BENNETT COMPANION EMT LIQUID OXYGEN	Jan 24, 1990	Substantially Equivalent	Puritan Bennett Corp.
K895082	VOYAGER PX	Jan 09, 1990	Substantially Equivalent	Smith-Perry Corp.
K882328	HI FLOW 50	Jun 28, 1988	Substantially Equivalent	Minnesota Valley Engineering, Inc.
K880183	PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT	Apr 14, 1988	Substantially Equivalent	Essex Cryogenics of Missouri, Inc.
K880101	LIBERATOR 53/STROLLER 50	Feb 29, 1988	Substantially Equivalent	Minnesota Valley Engineering, Inc.
K875352	HI FLOW PORTABLE LIQUID OXYGEN UNIT	Feb 29, 1988	Substantially Equivalent	Minnesota Valley Engineering, Inc.
K872449	NOMAD (BASE UNIT/PORTABLE UNIT)	Jul 21, 1987	Substantially Equivalent	Minnesota Valley Engineering, Inc.
K864280	ECONOL (PORTABLE) ECONO 30 & 40 LITER BASE UNIT	Jan 28, 1987	Substantially Equivalent	Smith-Taylor Mfg. Co., Div. Allied Medical Corp.
K863978	PORTABLE LIQUID OXYGEN UNIT (MODIFICATION)	Dec 15, 1986	Substantially Equivalent	Penox Technologies, Inc.
K863556	CSI LIQUID OXYGEN SYSTEM	Oct 15, 1986	Substantially Equivalent	Cryogenic Services, Inc.
K863205	SWIVEL COUPLER	Oct 02, 1986	Substantially Equivalent	Venmill Swivel, Co.
K860738	CTC 30, 40, 1 LIQUID OXYGEN LITERS	Aug 06, 1986	Substantially Equivalent	Cryodyne Technologies, Inc.
K861503	COMPANION LIQUID OXYGEN SYSTEM	Jun 25, 1986	Substantially Equivalent	Puritan Bennett Corp.
K860937	MARK 4 LIQUID OXYGEN SYSTEM	Mar 20, 1986	Substantially Equivalent	Puritan Bennett Corp.
K853775	PENOX HIGH FLOW MANIFOLD	Nov 29, 1985	Substantially Equivalent	Penox Technologies, Inc.
K853083	RESERVIOR-MASTERAIR PORTABLE-FREEDOMAIR	Sep 03, 1985	Substantially Equivalent	Home Medical Supply, Inc.
K841808	STROLLER SPRINT	May 16, 1984	Substantially Equivalent	Cryogenic Assoc.
K840534	LIQUID OXYGEN SYSTEM	Mar 02, 1984	Substantially Equivalent	The John Bunn Co.
K834290	INSPIRON LIQUID OXYGEN SYSTEM	Feb 04, 1984	Substantially Equivalent	Inspiron Corp.
K833994	PULSAIR I & II	Dec 12, 1983	Substantially Equivalent	Cryo Corp.
K832143	MARK III OXYGEN WALKER SYS. RESERVOIR	Aug 26, 1983	Substantially Equivalent	Linde Div. Union Carbide Corp.
K830337	MARK III OXYGEN WALKER SYS-LOW PRESS	Mar 17, 1983	Substantially Equivalent	Union Carbide Corp.
K830498	LIQUID OXYGEN SYSTEM	Mar 10, 1983	Substantially Equivalent	Puritan Bennett Corp.
K820836	MARK III OXYGEN WALKER SYSTEM	Apr 15, 1982	Substantially Equivalent	Union Carbide Corp.
K813453	UNIT, LIQUID, OXYGEN, PORTABLE	Jan 12, 1982	Substantially Equivalent	Pensee Medical Corp.
K812536	LINDE MARK II	Sep 23, 1981	Substantially Equivalent	Union Carbide Corp.
K811162	FLOWLOCK OXYGEN METER	May 08, 1981	Substantially Equivalent	Lifeguard Medical Products, Inc.
K810732	LINDE MARK II OXYGEN RESERV. TYPE OR-4	Mar 27, 1981	Substantially Equivalent	Union Carbide Corp.
K800742	LIBERATOR/STROLLER II SYSTEM	May 23, 1980	Substantially Equivalent	Cryogenic Assoc.
K791902	LINDE OXYGEN WALKER SYS. MARK II-L	Oct 17, 1979	Substantially Equivalent	Union Carbide Corp.
K780496	TRAVELAIR AND STATIONAIR	Apr 18, 1978	Substantially Equivalent	Cryomed Corp.
K780098	LIQUID OXYGEN UNIT, PORTABLE 73BYJ	Mar 02, 1978	Substantially Equivalent	Andonian Cryogenics, Inc.
K760787	LIBERATOR/STROLLER	Oct 22, 1976	Substantially Equivalent	Burditt & Calkins-Siemens-Elema