DRXClass II

Electrode, Electrocardiograph

21 CFR 870.2360 / Cardiovascular

DRX is the FDA product code for Electrode, Electrocardiograph, a class II device type, regulated under 21 CFR 870.2360. As of 2026-09-10, FDA records hold 329 510(k) clearances under this code, the most recent dated 2017-08-23, and 20 recalls.

Classification record

Product code: DRX
Device name: Electrode, Electrocardiograph
Regulation: 21 CFR 870.2360
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 329
Ingested recalls: 20

Clearances, product code DRX

By decision year

329 clearances under product code DRX with a decision year between 1976 and 2017, 1995 the highest year at 24.

Show the numbers

510(k) clearances under FDA product code DRX by decision year
Year	Clearances
1976	3
1977	7
1978	7
1979	11
1980	6
1981	9
1982	11
1983	6
1984	9
1985	14
1986	19
1987	23
1988	13
1989	21
1990	11
1991	13
1992	6
1993	7
1994	16
1995	24
1996	21
1997	8
1998	4
1999	8
2000	4
2001	1
2002	4
2003	8
2004	6
2005	4
2006	4
2007	3
2008	3
2009	7
2010	5
2013	1
2014	1
2017	1

Applicants with the most clearances

Product code DRX

Applicants holding the most 510(k) clearances under product code DRX
Applicant	Clearances
Graphic Controls Corp.	17
Nikomed U.S.A., Inc.	12
Lectec Corp.	11
Labeltape Meditect, Inc.	10
Leonhard Lang GmbH	10
Andover Medical, Inc.	8
Arbo Medical, Inc.	7
Medicotest, Inc.	7
Medtronic, Inc.	7
S & W Medico Teknik	7

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 179 companies shown, in name order