DXGClass II

Computer, Diagnostic, Pre-Programmed, Single-Function

21 CFR 870.1435 / Cardiovascular

DXG is the FDA product code for Computer, Diagnostic, Pre-Programmed, Single-Function, a class II device type, regulated under 21 CFR 870.1435. As of 2026-09-10, FDA records hold 177 510(k) clearances under this code, the most recent dated 2026-02-13, and 8 recalls.

Classification record

Product code: DXG
Device name: Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation: 21 CFR 870.1435
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: 177
Ingested recalls: 8

Clearances, product code DXG

By decision year

177 clearances under product code DXG with a decision year between 1976 and 2026, 1981 the highest year at 14.

Show the numbers

510(k) clearances under FDA product code DXG by decision year
Year	Clearances
1976	7
1977	9
1978	1
1979	7
1980	6
1981	14
1982	8
1983	6
1984	13
1985	13
1986	6
1987	12
1988	5
1989	4
1990	5
1991	2
1992	1
1994	2
1995	2
1996	2
1997	2
1999	2
2000	2
2001	1
2002	1
2003	2
2004	3
2006	3
2007	1
2008	5
2010	4
2011	3
2012	2
2013	3
2014	6
2015	1
2016	1
2017	1
2018	2
2019	2
2020	1
2021	1
2023	1
2025	1
2026	1

Applicants with the most clearances

Product code DXG

Applicants holding the most 510(k) clearances under product code DXG
Applicant	Clearances
Edwards Lifesciences LLC	11
Hewlett-Packard Co.	6
Lidco Ltd	6
Abbott Medical	5
Pulsion Medical Systems AG	5
Transonic Systems Inc	5
American Edwards Laboratories	4
Electro-Catheter Corp.	4
Honeywell, Inc.	4
Mennen Medical, Inc.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 58 companies shown, in name order