Product Code: DRM FDA class 2 21 CFR 870.5200

Compressor, Cardiac, External

Cardiovascular

The External Cardiac Compressor is a cardiovascular resuscitation device that mechanically applies rhythmic pressure to the chest to maintain circulation during cardiac arrest when manual CPR cannot be sustained consistently. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRM and it is regulated under 21 CFR 870.5200 within the Cardiovascular medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: DRM
Device Class: FDA class 2
Regulation Number: 870.5200
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 45 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K221700	AutoPulse NXT Resuscitation System	Mar 09, 2023	Substantially Equivalent	Zoll Circulation, Inc.
K211289	RMU-2000 Automated Chest Compression System	Nov 09, 2021	Substantially Equivalent	Defibtech, LLC
K173553	LUCAS 3 Chest Compression System	Feb 08, 2018	Substantially Equivalent	Jolife AB
K161768	LUCAS 3 Chest Compression System	Nov 09, 2016	Substantially Equivalent	Jolife AB
K153628	ROSC-U Mini Chest Compressor (RMCC)	Jan 30, 2016	Substantially Equivalent	Resuscitation International, LLC
K141809	RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM	Oct 27, 2014	Substantially Equivalent	Defibtech, LLC
K112998	AUTOPULSE RESUSCITATION SYSTEM MODEL 1000	Mar 15, 2012	Substantially Equivalent	Zoll Circulation
K102068	MINIATURIZE CHEST COMPRESSOR (MCC)	Nov 16, 2010	Substantially Equivalent	Resuscitation International
K090422	LUCAS 2	Jun 17, 2009	Substantially Equivalent	Jolife AB
K072527	AUTOPULSE RESUSCITATION SYSTEM, MODEL 100	Mar 19, 2008	Substantially Equivalent	Zoll Circulation
K073079	THUMPER, MODEL: 1008	Feb 14, 2008	Substantially Equivalent	Michigan Instruments, Inc.
K063602	AUTOPULSE RESUSCITATION SYSTEM MODEL100	Dec 21, 2006	Substantially Equivalent	Zoll Circulation
K062401	MODIFICATION TO LUCAS	Sep 28, 2006	Substantially Equivalent	Jolife AB
K062119	HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100	Sep 22, 2006	Substantially Equivalent	Medical Products Mfg., LLC
K053403	LUCAS	Feb 01, 2006	Substantially Equivalent	Jolife AB
K024215	ENERTRON CPR JACK	May 14, 2004	Substantially Equivalent	Enertron Engineering Co.
K040453	AUTOPULSE RESUSCITATION SYSTEM, MODEL 100	Mar 11, 2004	Substantially Equivalent	Revivant Corp.
K032852	MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100	Nov 12, 2003	Substantially Equivalent	Revivant Corp.
K022345	AUTOPULSE RESUSCITATION SYSTEM	Aug 15, 2002	Substantially Equivalent	Revivant Corp.
K011046	AUTOPULSE, MODEL 100	Oct 25, 2001	Substantially Equivalent	Revivant Corp.
K972525	THUMPER	Oct 02, 1997	Substantially Equivalent	Michigan Instruments, Inc.
K962237	THUMPER CARDIOPULMONARY RESUSCITATOR	Sep 05, 1996	Substantially Equivalent	Michigan Instruments, Inc.
K951124	CAD-2000 CARDIAC ASSIST DEVICE	Nov 20, 1995	Substantially Equivalent	Eee Medical Ent.
K922093	HASKEL CPR	Mar 14, 1994	Substantially Equivalent	Haskel, Inc.
K871271	HUNTLEIGH FLOWPRESS AC300 PUMP, SQ301/302/320 GAR.	Sep 15, 1987	Substantially Equivalent	Huntleigh Technology, Inc.
K871272	HUNTLEIGH FLOWPAC FP2000	Jun 25, 1987	Substantially Equivalent	Huntleigh Technology, Inc.
K855004	SWELL-RELIEF	Feb 12, 1986	Substantially Equivalent	D.A. Schulman, Inc.
K854734	MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE	Feb 10, 1986	Substantially Equivalent	Medasonics, Inc.
K851139	THUMPER CARDIOPULMONARY RESUSCITATOR 1005	May 15, 1985	Substantially Equivalent	Michigan Instruments, Inc.
K841275	FINE NEEDLE ASPIRATION DEVICE	Aug 17, 1984	Substantially Equivalent	Gyneco, Inc.
K841822	KEYMED SIGMOIDOSCOPE SUCTION UNIT	Jul 27, 1984	Substantially Equivalent	Keymed, Inc.
K841410	BUSH NECK W/TAP	Apr 18, 1984	Substantially Equivalent	Warne Surgical Products, Ltd.
K833879	CARDIOPULMONARY RESUSCITATOR	Dec 27, 1983	Substantially Equivalent	Michigan Instruments, Inc.
K811987	OXY-QUIK MARK IV OXYGEN INHALATOR	Jul 27, 1981	Substantially Equivalent	Oxequip Health Ind.
K811909	CARDIOPULMUNARY RESUSCITATOR	Jul 16, 1981	Substantially Equivalent	Michigan Instruments, Inc.
K801947	CPR TRAVELER	Nov 19, 1980	Substantially Equivalent	Cardia Concepts Corp.
K801946	CPR HELPER	Nov 19, 1980	Substantially Equivalent	Cardia Concepts Corp.
K801945	SAVE MOR	Nov 19, 1980	Substantially Equivalent	Cardia Concepts Corp.
K792458	PNEUPAC TEST SET, PT.#500-A250	Feb 05, 1980	Substantially Equivalent	Pneupac , Ltd.
K792454	PNEUPAC RESUSCITATOR INSTANT ACTION SET	Feb 05, 1980	Substantially Equivalent	Pneupac , Ltd.
K792452	PNEUPAC RESUSCITATOR INSTANT ACTION SET	Feb 05, 1980	Substantially Equivalent	Pneupac , Ltd.
K792451	PNEUPAC RESUSCITATOR INSTANT ACTION SET	Feb 05, 1980	Substantially Equivalent	Pneupac , Ltd.
K791145	CPR CONTROL SYSTEM	Jul 10, 1979	Substantially Equivalent	Pepin Distributing, Inc.
K790513	HLA-2000	May 31, 1979	Substantially Equivalent	Bdt Ent.
K761194	HLR QUICK-FIT HEART-LUNG RESUSCITATOR	Dec 09, 1976	Substantially Equivalent	Mckesson Corp.