Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JOQ · Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
108 daysmedian FDA review time
227 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173439 | Bloom2 Programmable Electrophysiology Stimulator | Fischer Medical | 2018-03-29 | 146 | 0 |
| K092913 | EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 | Ep Medsystems | 2009-10-16 | 24 | 0 |
| K072200 | STIMLAB | Micropace Pty, Ltd. | 2007-10-26 | 79 | 0 |
| K070743 | Z6 STIMULATOR | St Cardio Technologies, LLC | 2007-07-02 | 108 | 0 |
| K041442 | EP-4 CLINICAL STIMUTATOR | Ep Medsystems | 2004-09-14 | 105 | 1 |
| K040207 | EP-4 CLINICAL STIMULATOR | Ep Medsystems | 2004-02-27 | 28 | 2 |
| K011826 | EPS320 CARDIAC STIMULATOR | Micropace Pty, Ltd. | 2002-01-24 | 227 | 0 |
| K991293 | EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM D | Fischer Medical Technologies, Inc. | 2000-05-05 | 386 | 1 |
| K963579 | PACE-1A CARDIAC STIMULATOR | Radionics, Inc. | 1996-11-08 | 63 | 0 |
| K935590 | EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR | Ep Medical, Inc. | 1994-05-05 | 168 | 0 |
| K900553 | CONSTANT CURRENT STIMULATOR MODEL 022101 | Ep Technologies, Inc. | 1990-03-13 | 35 | 0 |
| K893094 | HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM | Heartware Intl. Corp. | 1989-10-02 | 157 | 0 |
| K861368 | MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR | Medtronic Vascular | 1986-08-04 | 115 | 0 |
| K852746 | EXTERNAL PACEMAKER TELECTRONICS TE200 | Seamed Corp. | 1985-09-12 | 77 | 0 |
| K844815 | CORDIS ELECTROPHYSIOLOGY STIMULATOR | Cordis Corp. | 1985-06-11 | 182 | 0 |
| K851091 | MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR | Medtronic Vascular | 1985-04-16 | 29 | 0 |
| K843718 | PROGRAMMABLE STIMULATOR 5326 | Medtronic Vascular | 1984-09-27 | 3 | 0 |
| K833421 | PROGRAMMABLE STIMULATOR 2352 | Medtronic Vascular | 1984-01-30 | 119 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda