Ep Technologies, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Ep Technologies, Inc.” (first 1988, latest 2005), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 76 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Boston Scientific, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 12 | 12 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 1 | 1 |
| JOQ | Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) | 1 | 1 |
Review panels
- Cardiovascular (15)
Most recent Ep Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K043257 | REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM | DRF | 2005-02-03 | 71 |
| K013349 | ASTRONOMER PLUS SYSTEM | DQK | 2002-04-09 | 182 |
| K003452 | POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D | DRF | 2000-12-07 | 30 |
| K940167 | DIAGNOSTIC I CATHETER | DRF | 1994-08-02 | 207 |
| K940168 | DIAGNOSTIC II CATHETER | DRF | 1994-07-27 | 201 |
| K924109 | STEEROCATH II | DRF | 1993-12-16 | 489 |
| K924108 | TRACFINDER II | DRF | 1993-12-16 | 489 |
| K913375 | TORQUE TUBE STEEROCATH(TM) | DRF | 1991-10-25 | 88 |
| K903880 | FRANZ(TM) STEERABLE COMBINATION CATHETER | DRF | 1990-10-12 | 51 |
| K900765 | STEEROCATH(TM) | DRF | 1990-05-07 | 80 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ep Technologies, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ep Technologies, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Ep Technologies, Inc.” (first 1988, latest 2005), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ep Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ep Technologies, Inc. is 76 days.
Which FDA product codes appear under Ep Technologies, Inc.?
The most frequent FDA product codes under this applicant name are DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording, 12); DQK (Computer, Diagnostic, Programmable, 1); DRQ (Amplifier And Signal Conditioner, Transducer Signal, 1).
Next steps
- See all 15 Ep Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRF, Ep Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.