Product Code: DRL FDA class 2 21 CFR 870.5325

Tester, Defibrillator

Cardiovascular

The Defibrillator Tester is a cardiovascular test equipment device used to verify the performance and energy output of defibrillators, ensuring they operate within specified parameters before clinical use. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRL and it is regulated under 21 CFR 870.5325 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

Registration Numbers

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Basic Information

Product Code: DRL
Device Class: FDA class 2
Regulation Number: 870.5325
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K190437	Delta 3300	Aug 28, 2019	Substantially Equivalent	Netech Corporation
K182905	UniPulse	Dec 14, 2018	Substantially Equivalent	Seaward Group
K153210	Defibrillator Analyzer Variable Load	Dec 21, 2015	Substantially Equivalent	Bc Group International, Inc.
K110192	DEFIBRILLATOR ANALYZER - DA-2006P	Feb 08, 2011	Substantially Equivalent	Bc Group International, Inc.
K083347	IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS	Dec 24, 2008	Substantially Equivalent	Fluke Biomedical
K072114	IMPULSE 6000D/7000DP	Jan 28, 2008	Substantially Equivalent	Fluke Biomedical
K062099	PHASE 3, MODEL DT-1	Jan 25, 2007	Substantially Equivalent	Datrend Systems, Inc.
K030547	MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE	Jul 11, 2003	Substantially Equivalent	Guardian Angel Products, Inc.
K963190	QA-40M DEFIBRILLATOR TESTER	Jul 01, 1997	Substantially Equivalent	Metron U.S., Inc.
K961595	DEFIBRILLATOR ANALYZER, DELTA 1000	Oct 29, 1996	Substantially Equivalent	Netech Corp.
K954391	MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER	Nov 17, 1995	Substantially Equivalent	Bio-Tek Instruments, Inc.
K941404	IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER	Jun 29, 1994	Substantially Equivalent	Hogan & Hartson
K934254	IMPULSE 3000 DEFIBRILLATOR ANALYZER	Nov 23, 1993	Substantially Equivalent	Dynatech/Nevada, Inc.
K904159	DEFIBRILLATOR ANALYZER MODEL QED-5	Mar 18, 1991	Substantially Equivalent	Bio-Tek Instruments, Inc.
K896985	ZAP-GUARD	Jul 31, 1990	Substantially Equivalent	Guardian Angel Products, Inc.
K895525	MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER	Jan 26, 1990	Substantially Equivalent	Matrix Medica, Inc.
K880780	HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG	May 12, 1988	Substantially Equivalent	First Medical Devices Corp.
K790394	DEFIBRILLATOR INTERAL PADDLE TEST LOAD	Mar 23, 1979	Substantially Equivalent	Physio-Control Corp.
K782033	CARDIAC CARE Q/C TEST KIT	Dec 15, 1978	Substantially Equivalent	Instrumentation Laboratory CO