BTYClass II

Calculator, Predicted Values, Pulmonary Function

21 CFR 868.1890 / Anesthesiology

BTY is the FDA product code for Calculator, Predicted Values, Pulmonary Function, a class II device type, regulated under 21 CFR 868.1890. As of 2026-09-10, FDA records hold 64 510(k) clearances under this code, the most recent dated 2026-08-20, and 4 recalls.

Classification record

Product code: BTY
Device name: Calculator, Predicted Values, Pulmonary Function
Regulation: 21 CFR 868.1890
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: Yes
Ingested clearances: 64
Ingested recalls: 4

Clearances, product code BTY

By decision year

64 clearances under product code BTY with a decision year between 1978 and 2026, 1986 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code BTY by decision year
Year	Clearances
1978	1
1979	1
1980	1
1981	4
1982	1
1983	2
1985	2
1986	7
1987	1
1988	2
1989	2
1991	1
1993	3
1994	4
1995	1
1997	1
1998	2
2000	2
2003	2
2004	1
2007	2
2008	3
2009	1
2010	1
2011	1
2012	3
2016	1
2017	1
2019	2
2020	1
2021	1
2022	1
2023	1
2024	3
2026	1

Applicants with the most clearances

Product code BTY

Applicants holding the most 510(k) clearances under product code BTY
Applicant	Clearances
Viasys Healthcare GmbH	5
Erich Jaeger, Inc.	4
Medical Graphics Corp.	4
Carefusion Germany 234 GmbH	3
Cosmed S.r.l.	3
eResearchTechnology GmbH	3
Medical Associated Services, Inc.	3
Ndd Medizitechnik AG	2
Pharmaquest Corp.	2
Pneumedics, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order