Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2360](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2360) → DRX — Electrode, Electrocardiograph # DRX · Electrode, Electrocardiograph _Cardiovascular · 21 CFR 870.2360 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX ## Overview - **Product Code:** DRX - **Device Name:** Electrode, Electrocardiograph - **Regulation:** [21 CFR 870.2360](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2360) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## Identification An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. ## Classification Rationale Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents. ## Recent Cleared Devices (20 of 329) Showing 20 most recent of 329 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K171244](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K171244.md) | Physiotrace | Nimbleheart, Inc. | Aug 23, 2017 | SESE | | [K140096](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K140096.md) | HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE | Hmicro, Inc. | Jul 24, 2014 | SESE | | [K123658](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K123658.md) | BIOMODULE 3-M1 | Zephyr Technology Corporation | Apr 24, 2013 | SESE | | [K101576](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K101576.md) | CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES | Team Innovations, Inc. | Jul 22, 2010 | SESE | | [K101685](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K101685.md) | IP-SET | Integral Process Sas | Jul 1, 2010 | SESE | | [K100129](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K100129.md) | AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X | Ambu A/S | Jun 11, 2010 | SESE | | [K093327](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K093327.md) | INTCO TAB ELECTRODE | Shanghai Intco Electrode Manufacturing Co., Ltd. | May 10, 2010 | SESE | | [K100315](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K100315.md) | 12 LEAD GLOVE | I Needmd, Inc. | Apr 23, 2010 | SESE | | [K092744](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K092744.md) | NEONATAL ECG ELECTRODE, M203KEN | R & D Medical Products, Inc. | Dec 10, 2009 | SESE | | [K092389](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K092389.md) | DISPOSAL ECG ELECTRODES, MODEL EASYRODE | Suzuken Co., Ltd. | Oct 13, 2009 | SESE | | [K090496](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K090496.md) | QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH | Cardiac Lead Technologies, Inc. | Sep 1, 2009 | SESE | | [K092291](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K092291.md) | SKINTACT AND VARIOUS OTHER TRADENAMES | Leonhard Lang GmbH | Aug 21, 2009 | SESE | | [K091856](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K091856.md) | CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES | Conmed Corporation | Aug 7, 2009 | SESE | | [K090180](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K090180.md) | TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE | Vermed, Inc. | Jun 17, 2009 | SESE | | [K083677](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K083677.md) | PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 | Commwell , Ltd. | Mar 10, 2009 | SESE | | [K083148](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K083148.md) | TELECTRODE WET GEL ECG ELECTRODE | Bio Protech, Inc. | Nov 7, 2008 | SESE | | [K080602](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K080602.md) | AUDICOR SENSOR, MODELS: 2.0, 3.0 | Inovise Medical, Inc. | Sep 25, 2008 | SESE | | [K080106](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K080106.md) | SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE | Leonhard Lang GmbH | Feb 1, 2008 | SESE | | [K073104](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K073104.md) | SKINTACT AND VARIOUS OTHER TRADENAMES | Leonhard Lang GmbH | Nov 16, 2007 | SESE | | [K071576](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX/K071576.md) | TEXTRONICS ECG ELECTRODE | Textronics, Inc. | Nov 2, 2007 | SESE | ## Top Applicants - Graphic Controls Corp. — 17 clearances - Nikomed U.S.A., Inc. — 12 clearances - Lectec Corp. — 11 clearances - Labeltape Meditect, Inc. — 10 clearances - Andover Medical, Inc. — 8 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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