DQKClass II

Computer, Diagnostic, Programmable

21 CFR 870.1425 / Cardiovascular

DQK is the FDA product code for Computer, Diagnostic, Programmable, a class II device type, regulated under 21 CFR 870.1425. As of 2026-09-10, FDA records hold 437 510(k) clearances under this code, the most recent dated 2026-08-21, and 124 recalls.

Classification record

Product code: DQK
Device name: Computer, Diagnostic, Programmable
Regulation: 21 CFR 870.1425
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: 438
Ingested recalls: 125

Clearances, product code DQK

By decision year

438 clearances under product code DQK with a decision year between 1976 and 2026, 2025 the highest year at 22.

Show the numbers

510(k) clearances under FDA product code DQK by decision year
Year	Clearances
1976	1
1977	1
1978	3
1979	3
1980	4
1981	5
1984	3
1985	2
1986	3
1987	4
1988	5
1989	1
1990	3
1991	3
1992	7
1993	4
1994	3
1995	9
1996	12
1997	2
1998	3
1999	10
2000	11
2001	11
2002	16
2003	14
2004	6
2005	16
2006	8
2007	13
2008	4
2009	12
2010	9
2011	12
2012	7
2013	13
2014	9
2015	7
2016	15
2017	7
2018	14
2019	15
2020	16
2021	16
2022	19
2023	21
2024	13
2025	22
2026	21

Applicants with the most clearances

Product code DQK

Applicants holding the most 510(k) clearances under product code DQK
Applicant	Clearances
Abbott Medical	46
Biosense Webster Inc	34
GE Medical Systems Information Technologies, Inc.	18
Edwards Lifesciences LLC	15
Boston Scientific Corporation	14
Acutus Medical, Inc.	12
GE Healthcare	10
iRhythm Technologies, Inc.	8
Cambridge Heart, Inc.	7
Centerline Biomedical	7

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 153 companies shown, in name order