BSRClass I

Stylet, Tracheal Tube

21 CFR 868.5790 / Anesthesiology

BSR is the FDA product code for Stylet, Tracheal Tube, a class I device type, regulated under 21 CFR 868.5790. As of 2026-09-10, FDA records hold 32 510(k) clearances under this code, the most recent dated 2017-08-11, and 16 recalls.

Classification record

Product code: BSR
Device name: Stylet, Tracheal Tube
Regulation: 21 CFR 868.5790
Device class: Class I
Review panel: Anesthesiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 32
Ingested recalls: 16

Clearances, product code BSR

By decision year

32 clearances under product code BSR with a decision year between 1977 and 2017, 1995 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code BSR by decision year
Year	Clearances
1977	2
1980	1
1983	1
1984	2
1987	1
1990	1
1991	4
1992	4
1993	2
1994	4
1995	5
1996	4
2017	1

Applicants with the most clearances

Product code BSR

Applicants holding the most 510(k) clearances under product code BSR
Applicant	Clearances
Augustine Medical, Inc.	3
Scientific Sales Intl., Inc.	3
Ackrad Laboratories	2
Laerdal Medical a/S	2
Polamedco, Inc.	2
Stebar Instrument Corp.	2
Aaron Medical, Inc.	1
American Hospital Supply	1
Bivona Medical Technologies	1
Coast Medical Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 122 companies shown, in name order