Product Code: DRO FDA class 2 21 CFR 870.5550

Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

Cardiovascular

The External Transcutaneous (Non-Invasive) Cardiac Pacemaker is a cardiovascular device used to deliver electrical stimulation to the heart through electrodes placed on the surface of the skin, providing temporary pacing support without the need for vascular access. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRO and it is regulated under 21 CFR 870.5550 within the Cardiovascular medical specialty. This device is designated as life-sustaining or life-supporting.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DRO
Device Class: FDA class 2
Regulation Number: 870.5550
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 84 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K012404	K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85	Oct 12, 2001	Substantially Equivalent	Katecho, Inc.
K012218	LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES	Oct 12, 2001	Substantially Equivalent	The Ludlow Company LP
K000660	ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413	Mar 28, 2000	Substantially Equivalent	Medical Data Electronics
K983232	PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT	Sep 15, 1999	Substantially Equivalent	Tz Medical, Inc.
K983196	PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)	Sep 15, 1999	Substantially Equivalent	Tz Medical, Inc.
K974034	PORTABLE INTENSIVE CARE UNIT	Mar 02, 1998	Substantially Equivalent	Medical Research Laboratories, Inc.
K962547	CARDIOSERV P	Mar 06, 1997	Substantially Equivalent	Marquette Electronics, Inc.
K963120	RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM	Feb 28, 1997	Substantially Equivalent	Marquette Electronics, Inc.
K961138	ESORT II + 400 SERIES MONITOR	Dec 10, 1996	Substantially Equivalent	Medical Data Electronics
K951593	LIFEPAK 11	Dec 29, 1995	Substantially Equivalent	Physio-Control Corp.
K950856	ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000	Dec 29, 1995	Substantially Equivalent	Zoll Medical Corp
K950483	HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR	May 22, 1995	Substantially Equivalent	Hewlett-Packard Co.
K926175	K-DEFIB/PACE CARBON ELECTRODE	Apr 15, 1993	Substantially Equivalent	Katecho, Inc.
K915757	MODELS M1722A, M1723A, M1724A DEFIBRILLATORS	Jul 30, 1992	Substantially Equivalent	Hewlett-Packard Co.
K915328	GEL-TAC	Jun 29, 1992	Substantially Equivalent	Katecho, Inc.
K914955	K-DEFIB/PACE ELECTRODE	May 14, 1992	Substantially Equivalent	Katecho, Inc.
K912599	QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC	Sep 11, 1991	Substantially Equivalent	Physio-Control Corp.
K911956	ZOLL PD-1400 PACER/DEFIBRILLATOR	Jul 31, 1991	Substantially Equivalent	Zmi Corp.
K910661	MODEL 205 SHOCK-TRODE	May 02, 1991	Substantially Equivalent	Cardiotronics, Inc.
K903437	DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER	Nov 16, 1990	Substantially Equivalent	Keller Medical Specialties Products, Inc.
K894492	NKA MODEL SEC-3102 CARDIAC STIMULATOR	Dec 20, 1989	Substantially Equivalent	Nihon Kohden America, Inc.
K894588	DEFIB/PACING PADS	Oct 26, 1989	Substantially Equivalent	Conmedcorp
K895729	R2 PACE PAD, MODEL 480	Oct 12, 1989	Substantially Equivalent	Darox Corp.
K895728	R2 PACE ADAPTOR CABLE, MODEL 196	Oct 12, 1989	Substantially Equivalent	Darox Corp.
K885166	ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES	May 01, 1989	Substantially Equivalent	Zmi Corp.
K885171	MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE	Jan 12, 1989	Substantially Equivalent	Andover Medical, Inc.
K880932	MRL PACETTE, 450SLL	Dec 16, 1988	Substantially Equivalent	Medical Research Laboratories, Inc.
K884532	TRIAD-EP II, PUSHBUTTON, CABLE INPUT	Nov 18, 1988	Substantially Equivalent	Cardiotronics, Inc.
K884530	TRIAD-EP II, PLATE INPUT	Nov 17, 1988	Substantially Equivalent	Cardiotronics, Inc.
K883304	TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY	Nov 09, 1988	Substantially Equivalent	Cardiotronics, Inc.
K883178	TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE	Nov 09, 1988	Substantially Equivalent	Cardiotronics, Inc.
K883523	TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE	Oct 06, 1988	Substantially Equivalent	Cardiotronics, Inc.
K883121	QUIK-PACE II ELECTRODES	Sep 20, 1988	Substantially Equivalent	Physio-Control Corp.
K883375	MODEL #918 MULTI-PADS	Aug 30, 1988	Substantially Equivalent	Cardiotronics, Inc.
K882338	MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE	Aug 30, 1988	Substantially Equivalent	Cardiotronics, Inc.
K882168	EXTERNAL PACEMAKER 2000 (EP2000)	Aug 19, 1988	Substantially Equivalent	Unomed, Inc.
K880936	TRIAD-EP	Jul 18, 1988	Substantially Equivalent	Cardiotronics, Inc.
K874447	DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC	Jan 27, 1988	Substantially Equivalent	Medac, Inc.
K871751	QUIK-PACE NONINVASIVE PACEMAKER	Dec 29, 1987	Substantially Equivalent	Physio-Control Corp.
K874090	300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER	Dec 15, 1987	Substantially Equivalent	Medac, Inc.
K873402	ZOLL NTP-1200 PACER/DEFIBRILLATOR	Nov 23, 1987	Substantially Equivalent	Zmi Corp.
K872778	PACESTART	Nov 04, 1987	Substantially Equivalent	Pacific Rim Engineering & Mfg.
K872368	MODIFIED VERSA STIM ELECTRODE LINE	Sep 18, 1987	Substantially Equivalent	Conmedcorp
K872012	LECTEC NON-INVASIVE PACING ELECTRODE	Jun 29, 1987	Substantially Equivalent	Lectec Corp.
K871971	MODIFIED PACE*AID MODEL 53	Jun 24, 1987	Substantially Equivalent	Cardiac Resucitator Corp.
K871538	STAT-PAD (TM)	Jun 24, 1987	Substantially Equivalent	Cardiac Resucitator Corp.
K871569	MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR	Jun 08, 1987	Substantially Equivalent	Cardiac Resucitator Corp.
K871176	PACE 10 NON-INVASIVE EXTERNAL PACEMAKER	Apr 23, 1987	Substantially Equivalent	Medac, Inc.
K864985	DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE	Mar 10, 1987	Substantially Equivalent	Medac, Inc.
K864989	ETP 180A NON-INVASIVE EXTERNAL PACEMAKER	Mar 03, 1987	Substantially Equivalent	Medac, Inc.
K864988	ETP 180E NON-INVASIVE EXTERNAL PACEMAKER	Mar 03, 1987	Substantially Equivalent	Medac, Inc.
K864987	DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE	Mar 03, 1987	Substantially Equivalent	Medac, Inc.
K864986	ETP 300 NON-INVASIVE EXTERNAL PACEMAKER	Mar 03, 1987	Substantially Equivalent	Medac, Inc.
K863547	MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE	Oct 31, 1986	Substantially Equivalent	Medtronic Vascular
K862298	ALTERNATE SIZE E-Z-PACE ELECTRODE	Jul 11, 1986	Substantially Equivalent	Medtronic Vascular
K854196	DCI MODEL EP-2 CLINICAL STIMULATOR	May 01, 1986	Substantially Equivalent	Digital Cardiovascular Instruments, Inc.
K860551	ETP 180 CARDIAC PACEMAKER (EXTERNAL)	Apr 30, 1986	Substantially Equivalent	Biotronics Corp.
K860283	AMI CARDIO-PAD	Mar 31, 1986	Substantially Equivalent	Andover Medical, Inc.
K855015	NONINVASIVE TEMP. PACEMAKER NTP-1000	Mar 31, 1986	Substantially Equivalent	Zmi Corp.
K854924	AMI E-Z-PACE ELECTODE	Feb 26, 1986	Substantially Equivalent	A.M.I. Corp.
K854853	NI-PACER 1	Feb 14, 1986	Substantially Equivalent	Associated Medical Devices, Inc.
K854117	AMENDMENT LIFEPAK 8, NPN 052	Jan 13, 1986	Substantially Equivalent	Physio-Control Corp.
K854233	CMI 3000	Jan 08, 1986	Substantially Equivalent	Cardio Management, Inc.
K853732	LIFEPAK 8 MODIFICATION	Dec 09, 1985	Substantially Equivalent	Physio-Control Corp.
K850812	EMERGIPACE - EXTERNAL PACEMAKER	Nov 05, 1985	Substantially Equivalent	Life Science Instrumentation, Inc.
K852958	PACEPAC	Oct 11, 1985	Substantially Equivalent	Medical Data Electronics
K850791	MDI 2000 - PULSE GENERATOR	Jun 19, 1985	Substantially Equivalent	Micromedical Devices, Inc.
K851248	AMENDMENT LIFEPAK 100, NPN 045	Apr 19, 1985	Substantially Equivalent	Physio-Control Corp.
K851247	AMENDMENT LIFEPAK 200, NPN 046	Apr 19, 1985	Substantially Equivalent	Physio-Control Corp.
K850596	PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY &	Mar 06, 1985	Substantially Equivalent	Cardiac Resucitator Corp.
K850170	HEART AID MODEL 97	Feb 14, 1985	Substantially Equivalent	Cardiac Resucitator Corp.
K844811	PACE AID MODEL 53	Jan 24, 1985	Substantially Equivalent	Cardiac Resucitator Corp.
K843547	PACE *AID MODEL 52	Dec 17, 1984	Substantially Equivalent	Cardiac Resucitator Corp.
K843358	HEART-AID MODEL 80	Nov 19, 1984	Substantially Equivalent	Cardiac Resucitator Corp.
K840353	PACEMAKER PULSE GENERATOR W/ELECTRODE	Apr 23, 1984	Substantially Equivalent	Ross Research, Inc.
K840047	LIFEPAK 7D	Feb 04, 1984	Substantially Equivalent	Physio-Control Corp.
K834262	TRANS-PACE	Feb 04, 1984	Substantially Equivalent	Micromedical Devices, Inc.
K832876	LIFEPAK 7P	Jan 30, 1984	Substantially Equivalent	Physio-Control Corp.
K822246	NONINVASIVE TEMPORARY PACEMAKER	Aug 06, 1982	Substantially Equivalent	Ross Research, Inc.
K821673	HEART*AID, ALS, MODEL 95	Aug 06, 1982	Substantially Equivalent	Cardiac Resucitator Corp.
K821152	HEART AID #90	Aug 06, 1982	Substantially Equivalent	Cardiac Resucitator Corp.
K820609	HEART *AID, #80	Aug 06, 1982	Substantially Equivalent	Cardiac Resucitator Corp.
K820507	PACE* AID MODEL 50	Aug 06, 1982	Substantially Equivalent	Cardiac Resucitator Corp.
K813553	PACE *AID	Jan 18, 1982	Substantially Equivalent	Cardiac Resucitator Corp.