DSHClass II

Recorder, Magnetic Tape, Medical

21 CFR 870.2800 / Cardiovascular

DSH is the FDA product code for Recorder, Magnetic Tape, Medical, a class II device type, regulated under 21 CFR 870.2800. As of 2026-09-10, FDA records hold 195 510(k) clearances under this code, the most recent dated 2026-07-09, and no recalls.

Classification record

Product code: DSH
Device name: Recorder, Magnetic Tape, Medical
Regulation: 21 CFR 870.2800
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: 195
Ingested recalls: 0

Clearances, product code DSH

By decision year

195 clearances under product code DSH with a decision year between 1976 and 2026, 1987 the highest year at 12.

Show the numbers

510(k) clearances under FDA product code DSH by decision year
Year	Clearances
1976	2
1977	2
1978	1
1979	8
1980	4
1981	6
1982	8
1983	10
1984	7
1985	6
1986	7
1987	12
1988	5
1989	7
1990	6
1991	9
1992	2
1993	3
1994	3
1995	8
1996	1
1997	5
1998	3
1999	3
2000	1
2001	1
2002	4
2003	2
2005	1
2006	1
2007	1
2008	1
2009	3
2010	2
2011	6
2012	2
2013	2
2014	1
2015	2
2016	2
2017	3
2018	3
2019	3
2020	4
2021	4
2022	4
2023	6
2024	2
2025	4
2026	2

Applicants with the most clearances

Product code DSH

Applicants holding the most 510(k) clearances under product code DSH
Applicant	Clearances
Del Mar Avionics	15
Bardy Diagnostics, Inc.	7
Oxford Medilog, Inc.	6
iRhythm Technologies, Inc.	6
Cardiocomm Solutions, Inc.	4
Cardionostics, Inc.	4
Reynolds Medical, Ltd.	4
Vasomedical, Inc.	4
Aequitron Medical, Inc.	3
American Edwards Laboratories	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 49 companies shown, in name order