BYIClass II

Percussor, Powered-Electric

21 CFR 868.5665 / Anesthesiology

BYI is the FDA product code for Percussor, Powered-Electric, a class II device type, regulated under 21 CFR 868.5665. As of 2026-09-10, FDA records hold 58 510(k) clearances under this code, the most recent dated 2026-04-30, and 3 recalls.

Classification record

Product code: BYI
Device name: Percussor, Powered-Electric
Regulation: 21 CFR 868.5665
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: 58
Ingested recalls: 3

Clearances, product code BYI

By decision year

58 clearances under product code BYI with a decision year between 1977 and 2026, 1980 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code BYI by decision year
Year	Clearances
1977	1
1979	1
1980	4
1981	4
1982	2
1984	1
1985	1
1986	3
1988	3
1989	2
1990	1
1991	1
1994	3
1995	1
1997	1
1998	2
1999	1
2000	1
2001	1
2003	2
2004	1
2005	2
2006	1
2007	1
2010	1
2011	1
2012	1
2013	3
2015	1
2017	1
2018	1
2021	2
2022	1
2024	3
2025	1
2026	1

Applicants with the most clearances

Product code BYI

Applicants holding the most 510(k) clearances under product code BYI
Applicant	Clearances
Electromed, Inc.	5
American Biosystems, Inc.	4
Dymedso, Inc.	3
Strom Corp.	3
Advanced Respiratory	2
Bradstreet Clinical Research Assoc., Inc.	2
Cussionair Therapy Products, Inc.	2
Hudson Oxygen Therapy Sales Co.	2
Med Systems	2
Airphysio Pty, Ltd.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order