DXHClass II

Transmitters And Receivers, Electrocardiograph, Telephone

21 CFR 870.2920 / Cardiovascular

DXH is the FDA product code for Transmitters And Receivers, Electrocardiograph, Telephone, a class II device type, regulated under 21 CFR 870.2920. As of 2026-09-10, FDA records hold 297 510(k) clearances under this code, the most recent dated 2026-02-13, and 10 recalls.

Classification record

Product code: DXH
Device name: Transmitters And Receivers, Electrocardiograph, Telephone
Regulation: 21 CFR 870.2920
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 297
Ingested recalls: 10

Clearances, product code DXH

By decision year

297 clearances under product code DXH with a decision year between 1976 and 2026, 1988 the highest year at 13.

Show the numbers

510(k) clearances under FDA product code DXH by decision year
Year	Clearances
1976	4
1977	6
1978	6
1979	3
1980	2
1981	9
1982	8
1983	6
1984	5
1985	7
1986	6
1987	5
1988	13
1989	10
1990	9
1991	10
1992	10
1993	5
1994	11
1995	12
1996	10
1997	13
1998	8
1999	12
2000	7
2001	9
2002	5
2003	6
2004	5
2005	6
2006	7
2007	3
2008	7
2009	2
2010	2
2012	1
2013	3
2014	6
2015	4
2016	1
2017	5
2018	4
2019	6
2020	5
2021	3
2022	4
2023	1
2025	4
2026	1

Applicants with the most clearances

Product code DXH

Applicants holding the most 510(k) clearances under product code DXH
Applicant	Clearances
Card Guard Scientific Survival, Ltd.	28
Instromedix, Inc.	17
Medtronic, Inc.	15
AliveCor	10
Universal Medical, Inc.	8
Survival Technology, Inc.	7
Paceart, Inc.	6
Aerotel Ltd.	5
Intermedics, Inc.	5
Physio Control, Inc.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 75 companies shown, in name order