BYJClass II

Unit, Liquid-Oxygen, Portable

21 CFR 868.5655 / Anesthesiology

BYJ is the FDA product code for Unit, Liquid-Oxygen, Portable, a class II device type, regulated under 21 CFR 868.5655. As of 2026-09-10, FDA records hold 55 510(k) clearances under this code, the most recent dated 2013-07-19, and 6 recalls.

Classification record

Product code: BYJ
Device name: Unit, Liquid-Oxygen, Portable
Regulation: 21 CFR 868.5655
Device class: Class II
Review panel: Anesthesiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 55
Ingested recalls: 6

Clearances, product code BYJ

By decision year

55 clearances under product code BYJ with a decision year between 1976 and 2013, 1986 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code BYJ by decision year
Year	Clearances
1976	1
1978	2
1979	1
1980	1
1981	3
1982	2
1983	4
1984	3
1985	2
1986	6
1987	2
1988	4
1990	3
1993	1
1994	2
1996	1
1997	1
1999	1
2001	1
2004	3
2005	2
2007	2
2008	3
2010	1
2011	1
2012	1
2013	1

Applicants with the most clearances

Product code BYJ

Applicants holding the most 510(k) clearances under product code BYJ
Applicant	Clearances
Medtronic, Inc.	7
Union Carbide Corp.	5
Minnesota Valley Engineering, Inc.	4
Essex Cryogenics of Missouri, Inc.	3
Respironics, Inc.	3
Caire, Inc.	2
Cryogenic Assoc.	2
Essex Industries, Inc	2
Penox Technologies, Inc.	2
Precision Medical, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code