Atlas FDA

DRL

19 FDA 510(k) clearances · Product code

98 daysmedian time to decision
230 days90th percentile
19clearances measured

FDA profile

Official device name
Tester, Defibrillator
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5325
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
1998: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Delta 3300 (K190437)Netech Corporation2019-08-28
UniPulse (K182905)Seaward Group2018-12-14
Defibrillator Analyzer Variable Load (K153210)Bc Group International, Inc.2015-12-21
DEFIBRILLATOR ANALYZER - DA-2006P (K110192)Bc Group International, Inc.2011-02-08
IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS (K083347)Fluke Biomedical2008-12-24
IMPULSE 6000D/7000DP (K072114)Fluke Biomedical2008-01-28
PHASE 3, MODEL DT-1 (K062099)Datrend Systems, Inc.2007-01-25
MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE (K030547)Guardian Angel Products, Inc.2003-07-11
QA-40M DEFIBRILLATOR TESTER (K963190)Metron U.S., Inc.1997-07-01
DEFIBRILLATOR ANALYZER, DELTA 1000 (K961595)Netech Corp.1996-10-29
MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER (K954391)Bio-Tek Instruments, Inc.1995-11-17
IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER (K941404)Hogan & Hartson1994-06-29
IMPULSE 3000 DEFIBRILLATOR ANALYZER (K934254)Dynatech/Nevada, Inc.1993-11-23
DEFIBRILLATOR ANALYZER MODEL QED-5 (K904159)Bio-Tek Instruments, Inc.1991-03-18
ZAP-GUARD (K896985)Guardian Angel Products, Inc.1990-07-31
MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER (K895525)Matrix Medica, Inc.1990-01-26
HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG (K880780)First Medical Devices Corp.1988-05-12
DEFIBRILLATOR INTERAL PADDLE TEST LOAD (K790394)Physio-Control Corp.1979-03-23
CARDIAC CARE Q/C TEST KIT (K782033)Instrumentation Laboratory CO1978-12-15

Track DRL automatically

Every clearance here is in the API, with alerts when new ones post.