Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ep Medsystems — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
112 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092913 | EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 | Ep Medsystems | 2009-10-16 | 24 | 0 |
| K073709 | MODIFICATION TO VIEWMATE SYSTEM | Ep Medsystems | 2008-03-11 | 71 | 0 |
| K071028 | VIEWMATE SYSTEM | Ep Medsystems | 2007-05-01 | 20 | 0 |
| K070706 | EP-WORKMATE | Ep Medsystems | 2007-04-11 | 28 | 1 |
| K063113 | EP-WORKMATE | Ep Medsystems | 2006-10-27 | 16 | 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 |
| K031066 | VIEWMATE ULTRASOUND IMAGING SYSTEM | Ep Medsystems | 2003-10-17 | 197 | 0 |
| K032225 | EP-WORKMATE WITH RPM SYSTEM | Ep Medsystems | 2003-08-20 | 30 | 0 |
| K991001 | MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSY | Ep Medsystems | 1999-07-15 | 112 | 0 |
| K984150 | PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHY | Ep Medsystems | 1999-02-22 | 95 | 0 |
| K961513 | PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SE | Ep Medsystems | 1996-05-13 | 24 | 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