Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart F — Cardiovascular Therapeutic Devices](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices) → [21 CFR 870.5325](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5325) → DRL — Tester, Defibrillator # DRL · Tester, Defibrillator _Cardiovascular · 21 CFR 870.5325 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL ## Overview - **Product Code:** DRL - **Device Name:** Tester, Defibrillator - **Regulation:** [21 CFR 870.5325](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/870.5325) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A defibrillator tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. Some testers also provide waveform information. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (19 of 19) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K190437](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K190437.md) | Delta 3300 | Netech Corporation | Aug 28, 2019 | SESE | | [K182905](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K182905.md) | UniPulse | Seaward Group | Dec 14, 2018 | SESE | | [K153210](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K153210.md) | Defibrillator Analyzer Variable Load | Bc Group International, Inc. | Dec 21, 2015 | SESE | | [K110192](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K110192.md) | DEFIBRILLATOR ANALYZER - DA-2006P | Bc Group International, Inc. | Feb 8, 2011 | SESE | | [K083347](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K083347.md) | IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS | Fluke Biomedical | Dec 24, 2008 | SESE | | [K072114](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K072114.md) | IMPULSE 6000D/7000DP | Fluke Biomedical | Jan 28, 2008 | SESE | | [K062099](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K062099.md) | PHASE 3, MODEL DT-1 | Datrend Systems, Inc. | Jan 25, 2007 | SESE | | [K030547](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K030547.md) | MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE | Guardian Angel Products, Inc. | Jul 11, 2003 | SESE | | [K963190](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K963190.md) | QA-40M DEFIBRILLATOR TESTER | Metron U.S., Inc. | Jul 1, 1997 | SESE | | [K961595](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K961595.md) | DEFIBRILLATOR ANALYZER, DELTA 1000 | Netech Corp. | Oct 29, 1996 | SESE | | [K954391](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K954391.md) | MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER | Bio-Tek Instruments, Inc. | Nov 17, 1995 | SESE | | [K941404](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K941404.md) | IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER | Hogan & Hartson | Jun 29, 1994 | SESE | | [K934254](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K934254.md) | IMPULSE 3000 DEFIBRILLATOR ANALYZER | Dynatech/Nevada, Inc. | Nov 23, 1993 | SESE | | [K904159](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K904159.md) | DEFIBRILLATOR ANALYZER MODEL QED-5 | Bio-Tek Instruments, Inc. | Mar 18, 1991 | SESE | | [K896985](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K896985.md) | ZAP-GUARD | Guardian Angel Products, Inc. | Jul 31, 1990 | SESE | | [K895525](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K895525.md) | MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER | Matrix Medica, Inc. | Jan 26, 1990 | SESE | | [K880780](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K880780.md) | HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG | First Medical Devices Corp. | May 12, 1988 | SESE | | [K790394](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K790394.md) | DEFIBRILLATOR INTERAL PADDLE TEST LOAD | Physio-Control Corp. | Mar 23, 1979 | SESE | | [K782033](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL/K782033.md) | CARDIAC CARE Q/C TEST KIT | Instrumentation Laboratory CO | Dec 15, 1978 | SESE | ## Top Applicants - Bc Group International, Inc. — 2 clearances - Bio-Tek Instruments, Inc. — 2 clearances - Fluke Biomedical — 2 clearances - Guardian Angel Products, Inc. — 2 clearances - Datrend Systems, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL](https://fda.innolitics.com/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/DRL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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