BTRClass II

Tube, Tracheal (W/Wo Connector)

21 CFR 868.5730 / Anesthesiology

BTR is the FDA product code for Tube, Tracheal (W/Wo Connector), a class II device type, regulated under 21 CFR 868.5730. As of 2026-09-10, FDA records hold 241 510(k) clearances under this code, the most recent dated 2026-06-12, and 226 recalls.

Classification record

Product code: BTR
Device name: Tube, Tracheal (W/Wo Connector)
Regulation: 21 CFR 868.5730
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: 242
Ingested recalls: 227

Clearances, product code BTR

By decision year

242 clearances under product code BTR with a decision year between 1976 and 2026, 1993 the highest year at 27.

Show the numbers

510(k) clearances under FDA product code BTR by decision year
Year	Clearances
1976	1
1977	1
1978	5
1979	6
1980	3
1981	9
1982	6
1983	6
1984	11
1985	7
1986	12
1987	9
1988	6
1989	4
1990	2
1991	3
1992	5
1993	27
1994	8
1995	12
1996	8
1997	2
1998	3
1999	4
2000	4
2002	4
2003	1
2004	3
2005	8
2006	1
2007	1
2008	7
2009	7
2010	3
2011	2
2012	5
2013	1
2014	3
2015	3
2016	1
2017	2
2018	5
2019	5
2020	3
2021	1
2022	1
2023	1
2024	1
2025	7
2026	2

Applicants with the most clearances

Product code BTR

Applicants holding the most 510(k) clearances under product code BTR
Applicant	Clearances
Sheridan Catheter Corp.	11
Mallinckrodt Critical Care	10
Rusch, Inc.	9
Bivona Medical Technologies	8
Polamedco, Inc.	7
Rusch Intl.	7
Unomedical Sdn Bhd	7
Medtronic, Inc.	6
Boston Medical Products, Inc.	5
Etview, Ltd.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 116 companies shown, in name order