Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5550](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5550) → DRO — Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) # DRO · Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) _Cardiovascular · 21 CFR 870.5550 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO ## Overview - **Product Code:** DRO - **Device Name:** Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) - **Regulation:** [21 CFR 870.5550](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5550) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **Life-sustaining:** yes ## Identification An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles. ## Classification Rationale Class II. The special controls for this device are: ## Special Controls *Classification.* Class II. The special controls for this device are:(1) “American National Standards Institute/American Association for Medical Instrumentation's DF-21 ‘Cardiac Defibrillator Devices’ ” 2d ed., 1996, and (2) “The maximum pulse amplitude should not exceed 200 milliamperes. The maximum pulse duration should not exceed 50 milliseconds.” ## Recent Cleared Devices (20 of 84) Showing 20 most recent of 84 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K012404](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K012404.md) | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 | Katecho, Inc. | Oct 12, 2001 | SESE | | [K012218](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K012218.md) | LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES | The Ludlow Company LP | Oct 12, 2001 | SESE | | [K000660](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K000660.md) | ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 | Medical Data Electronics | Mar 28, 2000 | SESE | | [K983232](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K983232.md) | PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT | Tz Medical, Inc. | Sep 15, 1999 | SESE | | [K983196](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K983196.md) | PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) | Tz Medical, Inc. | Sep 15, 1999 | SESE | | [K974034](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K974034.md) | PORTABLE INTENSIVE CARE UNIT | Medical Research Laboratories, Inc. | Mar 2, 1998 | SESE | | [K962547](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K962547.md) | CARDIOSERV P | Marquette Electronics, Inc. | Mar 6, 1997 | SESE | | [K963120](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K963120.md) | RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM | Marquette Electronics, Inc. | Feb 28, 1997 | SESE | | [K961138](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K961138.md) | ESORT II + 400 SERIES MONITOR | Medical Data Electronics | Dec 10, 1996 | SESE | | [K951593](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K951593.md) | LIFEPAK 11 | Physio-Control Corp. | Dec 29, 1995 | SESE | | [K950856](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K950856.md) | ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 | Zoll Medical Corp | Dec 29, 1995 | SESE | | [K950483](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K950483.md) | HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR | Hewlett-Packard Co. | May 22, 1995 | SESE | | [K926175](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K926175.md) | K-DEFIB/PACE CARBON ELECTRODE | Katecho, Inc. | Apr 15, 1993 | SESE | | [K915757](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K915757.md) | MODELS M1722A, M1723A, M1724A DEFIBRILLATORS | Hewlett-Packard Co. | Jul 30, 1992 | SESE | | [K915328](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K915328.md) | GEL-TAC | Katecho, Inc. | Jun 29, 1992 | SESE | | [K914955](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K914955.md) | K-DEFIB/PACE ELECTRODE | Katecho, Inc. | May 14, 1992 | SESE | | [K912599](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K912599.md) | QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC | Physio-Control Corp. | Sep 11, 1991 | SESE | | [K911956](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K911956.md) | ZOLL PD-1400 PACER/DEFIBRILLATOR | Zmi Corp. | Jul 31, 1991 | SESE | | [K910661](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K910661.md) | MODEL 205 SHOCK-TRODE | Cardiotronics, Inc. | May 2, 1991 | SESE | | [K903437](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO/K903437.md) | DISPOS ACCESS EXTERNAL CARDIAC PACEMAKER | Keller Medical Specialties Products, Inc. | Nov 16, 1990 | SESE | ## Top Applicants - Cardiac Resucitator Corp. — 13 clearances - Physio-Control Corp. — 10 clearances - Cardiotronics, Inc. — 9 clearances - Medac, Inc. — 8 clearances - Katecho, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com