DRMClass II

Compressor, Cardiac, External

21 CFR 870.5200 / Cardiovascular

DRM is the FDA product code for Compressor, Cardiac, External, a class II device type, regulated under 21 CFR 870.5200. As of 2026-09-10, FDA records hold 45 510(k) clearances under this code, the most recent dated 2023-03-09, and 12 recalls.

Classification record

Product code: DRM
Device name: Compressor, Cardiac, External
Regulation: 21 CFR 870.5200
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: No
Ingested clearances: 45
Ingested recalls: 12

Clearances, product code DRM

By decision year

45 clearances under product code DRM with a decision year between 1976 and 2023, 1980 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code DRM by decision year
Year	Clearances
1976	1
1979	2
1980	7
1981	2
1983	1
1984	3
1985	1
1986	2
1987	2
1994	1
1995	1
1996	1
1997	1
2001	1
2002	1
2003	1
2004	2
2006	4
2008	2
2009	1
2010	1
2012	1
2014	1
2016	2
2018	1
2021	1
2023	1

Applicants with the most clearances

Product code DRM

Applicants holding the most 510(k) clearances under product code DRM
Applicant	Clearances
Michigan Instruments	6
Jolife AB	5
Pneupac, Ltd.	4
Revivant Corp.	4
ZOLL Circulation, Inc.	4
Cardia Concepts Corp.	3
Defibtech LLC	2
Huntleigh Technology, Inc.	2
Resuscitation International	2
Bdt Ent.	1

Companies listing this code with FDA

Companies whose registered establishments list this code