Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: DRO FDA class 2

Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

Cardiovascular

View full classification →

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.

510(k) Clearances

50+ matches

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

K983196

PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)

Sep 15, 1999

Substantially Equivalent

TZ MEDICAL, INC.

K983232

PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT

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

K950856

ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000

Dec 29, 1995

Substantially Equivalent

ZOLL MEDICAL CORP.

K951593

LIFEPAK 11

Dec 29, 1995

Substantially Equivalent

PHYSIO-CONTROL 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

CONMED CORP.

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.

K883178

TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE

Nov 09, 1988

Substantially Equivalent

CARDIOTRONICS, INC.

K883304

TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY

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

CONMED CORP.

K872012

LECTEC NON-INVASIVE PACING ELECTRODE

Jun 29, 1987

Substantially Equivalent

LECTEC CORP.

K871538

STAT-PAD (TM)

Jun 24, 1987

Substantially Equivalent

CARDIAC RESUCITATOR CORP.

K871971

MODIFIED PACE*AID MODEL 53

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.

K864987

DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE

Mar 03, 1987

Substantially Equivalent

MEDAC, INC.

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

Popular Product Codes

Commonly searched

DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump