Atlas FDA

JOQ

18 FDA 510(k) clearances · Product code

108 daysmedian time to decision
227 days90th percentile
18clearances measured

FDA profile

Official device name
Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1750
Medical specialty
Cardiovascular
Flags
Life-sustaining
Adverse events (MAUDE)
2006: 12 · 2007: 8 · 2009: 3 · 2010: 11 · 2011: 9 · 2012: 25
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Bloom2 Programmable Electrophysiology Stimulator (K173439)Fischer Medical2018-03-29
EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 (K092913)Ep Medsystems2009-10-16
STIMLAB (K072200)Micropace Pty, Ltd.2007-10-26
Z6 STIMULATOR (K070743)St Cardio Technologies, LLC2007-07-02
EP-4 CLINICAL STIMUTATOR (K041442)Ep Medsystems2004-09-14
EP-4 CLINICAL STIMULATOR (K040207)Ep Medsystems2004-02-27
EPS320 CARDIAC STIMULATOR (K011826)Micropace Pty, Ltd.2002-01-24
EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR (K991293)Fischer Medical Technologies, Inc.2000-05-05
PACE-1A CARDIAC STIMULATOR (K963579)Radionics, Inc.1996-11-08
EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR (K935590)Ep Medical, Inc.1994-05-05
CONSTANT CURRENT STIMULATOR MODEL 022101 (K900553)Ep Technologies, Inc.1990-03-13
HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM (K893094)Heartware Intl. Corp.1989-10-02
MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR (K861368)Medtronic Vascular1986-08-04
EXTERNAL PACEMAKER TELECTRONICS TE200 (K852746)Seamed Corp.1985-09-12
CORDIS ELECTROPHYSIOLOGY STIMULATOR (K844815)Cordis Corp.1985-06-11
MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR (K851091)Medtronic Vascular1985-04-16
PROGRAMMABLE STIMULATOR 5326 (K843718)Medtronic Vascular1984-09-27
PROGRAMMABLE STIMULATOR 2352 (K833421)Medtronic Vascular1984-01-30

Track JOQ automatically

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