BTTClass II

Humidifier, Respiratory Gas, (Direct Patient Interface)

21 CFR 868.5450 / Anesthesiology

BTT is the FDA product code for Humidifier, Respiratory Gas, (Direct Patient Interface), a class II device type, regulated under 21 CFR 868.5450. As of 2026-09-10, FDA records hold 222 510(k) clearances under this code, the most recent dated 2026-08-27, and 70 recalls.

Classification record

Product code: BTT
Device name: Humidifier, Respiratory Gas, (Direct Patient Interface)
Regulation: 21 CFR 868.5450
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: No
Ingested clearances: 222
Ingested recalls: 70

Clearances, product code BTT

By decision year

222 clearances under product code BTT with a decision year between 1976 and 2026, 1984 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code BTT by decision year
Year	Clearances
1976	8
1977	3
1978	9
1979	2
1980	7
1981	5
1982	4
1983	5
1984	10
1985	5
1986	2
1987	9
1988	7
1989	6
1990	7
1991	1
1992	6
1993	3
1994	3
1995	1
1996	4
1997	4
1998	1
1999	2
2000	8
2001	6
2002	2
2003	6
2004	6
2005	4
2006	4
2007	6
2008	4
2009	1
2010	4
2011	3
2012	2
2013	6
2014	7
2015	1
2016	3
2017	3
2018	2
2019	1
2020	2
2021	2
2022	3
2023	7
2024	7
2025	4
2026	4

Applicants with the most clearances

Product code BTT

Applicants holding the most 510(k) clearances under product code BTT
Applicant	Clearances
Fisher & Paykel Healthcare, Inc.	28
Fisher & Paykel Allied Products, Ltd.	11
Vapotherm Inc.	10
Travenol Laboratories, S.A.	9
Respiratory Care, Inc.	8
Abbott Medical	6
Automatic Liquid Packaging, Inc.	6
Fisher & Paykel Electronics, Ltd.	6
Hudson Respiratory Care, Inc.	5
Pegasus Research Corp.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 93 companies shown, in name order