Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ep Technologies, Inc. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
489 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K043257 | REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM | Ep Technologies, Inc. | 2005-02-03 | 71 | 0 |
| K013349 | ASTRONOMER PLUS SYSTEM | Ep Technologies, Inc. | 2002-04-09 | 182 | 0 |
| K003452 | POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,700 | Ep Technologies, Inc. | 2000-12-07 | 30 | 0 |
| K940167 | DIAGNOSTIC I CATHETER | Ep Technologies, Inc. | 1994-08-02 | 207 | 0 |
| K940168 | DIAGNOSTIC II CATHETER | Ep Technologies, Inc. | 1994-07-27 | 201 | 0 |
| K924108 | TRACFINDER II | Ep Technologies, Inc. | 1993-12-16 | 489 | 0 |
| K924109 | STEEROCATH II | Ep Technologies, Inc. | 1993-12-16 | 489 | 0 |
| K913375 | TORQUE TUBE STEEROCATH(TM) | Ep Technologies, Inc. | 1991-10-25 | 88 | 0 |
| K903880 | FRANZ(TM) STEERABLE COMBINATION CATHETER | Ep Technologies, Inc. | 1990-10-12 | 51 | 0 |
| K900765 | STEEROCATH(TM) | Ep Technologies, Inc. | 1990-05-07 | 80 | 0 |
| K900452 | QUATTRO CATHETER | Ep Technologies, Inc. | 1990-03-14 | 43 | 0 |
| K900553 | CONSTANT CURRENT STIMULATOR MODEL 022101 | Ep Technologies, Inc. | 1990-03-13 | 35 | 0 |
| K892207 | FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED | Ep Technologies, Inc. | 1989-06-12 | 70 | 0 |
| K885252 | MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001 | Ep Technologies, Inc. | 1989-01-13 | 30 | 0 |
| K881853 | FRANZ CATHETER | Ep Technologies, Inc. | 1988-07-18 | 76 | 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