BYEClass II

Attachment, Breathing, Positive End Expiratory Pressure

21 CFR 868.5965 / Anesthesiology

BYE is the FDA product code for Attachment, Breathing, Positive End Expiratory Pressure, a class II device type, regulated under 21 CFR 868.5965. As of 2026-09-10, FDA records hold 80 510(k) clearances under this code, the most recent dated 2016-04-29, and 10 recalls.

Classification record

Product code: BYE
Device name: Attachment, Breathing, Positive End Expiratory Pressure
Regulation: 21 CFR 868.5965
Device class: Class II
Review panel: Anesthesiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 80
Ingested recalls: 10

Clearances, product code BYE

By decision year

80 clearances under product code BYE with a decision year between 1976 and 2016, 1988 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code BYE by decision year
Year	Clearances
1976	1
1977	1
1978	2
1980	3
1981	1
1982	1
1983	4
1984	2
1985	2
1986	5
1987	5
1988	7
1989	5
1990	7
1991	3
1992	2
1993	2
1994	1
1995	3
1996	2
1997	2
1998	1
1999	2
2000	1
2003	1
2005	1
2007	1
2008	1
2009	3
2010	1
2011	3
2013	1
2014	2
2016	1

Applicants with the most clearances

Product code BYE

Applicants holding the most 510(k) clearances under product code BYE
Applicant	Clearances
Medtronic, Inc.	6
Vital Signs, Inc.	6
Respironics, Inc.	5
Devilbiss Health Care, Inc.	3
Draeger, Inc.	3
Engineered Medical Systems, LLC	3
Life Design Systems, Inc.	3
Med Air Technology, Inc.	2
Neoforce Group, Inc.	2
GE Healthcare	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 67 companies shown, in name order