BTIClass II

Compressor, Air, Portable

21 CFR 868.6250 / Anesthesiology

BTI is the FDA product code for Compressor, Air, Portable, a class II device type, regulated under 21 CFR 868.6250. As of 2026-09-10, FDA records hold 74 510(k) clearances under this code, the most recent dated 2013-10-24, and 5 recalls.

Classification record

Product code: BTI
Device name: Compressor, Air, Portable
Regulation: 21 CFR 868.6250
Device class: Class II
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: 74
Ingested recalls: 5

Clearances, product code BTI

By decision year

74 clearances under product code BTI with a decision year between 1977 and 2013, 1986 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code BTI by decision year
Year	Clearances
1977	2
1978	1
1979	1
1980	4
1981	3
1982	3
1983	4
1984	1
1985	4
1986	5
1987	5
1988	2
1989	3
1990	2
1991	3
1992	3
1993	1
1994	3
1995	5
1997	1
1998	1
2001	3
2002	1
2003	2
2004	4
2005	2
2006	1
2008	1
2009	1
2012	1
2013	1

Applicants with the most clearances

Product code BTI

Applicants holding the most 510(k) clearances under product code BTI
Applicant	Clearances
Medical Industries America, Inc.	4
Timeter Instrument Corp.	4
Precision Medical, Inc.	3
Ashai Co., Ltd.	2
Devilbiss Health Care, Inc.	2
Ekom s.r.o.	2
Mountain Medical Equipment, Inc.	2
Siemens Elema AB	2
The John Bunn Co.	2
Thomas Industries	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 66 companies shown, in name order