Ep Medsystems: FDA filings under this applicant name
FDA lists 15 510(k) clearances under 2 spellings of the applicant name “Ep Medsystems” (first 1996, latest 2009), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 30 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | 5 | 5 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 3 | 3 |
| JOQ | Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) | 3 | 3 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 2 |
| DYB | Introducer, Catheter | 1 | 1 |
| ITN | Splint, Denis Brown | 1 | 1 |
Review panels
- Cardiovascular (12)
- Radiology (2)
- Physical Medicine (1)
Most recent Ep Medsystems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092913 | EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 | JOQ | 2009-10-16 | 24 |
| K073709 | MODIFICATION TO VIEWMATE SYSTEM | IYN | 2008-03-11 | 71 |
| K071028 | VIEWMATE SYSTEM | ITN | 2007-05-01 | 20 |
| K070706 | EP-WORKMATE | DQK | 2007-04-11 | 28 |
| K063277 | MAPMATE | DQK | 2006-11-30 | 30 |
| K063113 | EP-WORKMATE | DQK | 2006-10-27 | 16 |
| K041442 | EP-4 CLINICAL STIMUTATOR | JOQ | 2004-09-14 | 105 |
| K033963 | EP DEFLECTABLE CATHETERS | DRF | 2004-04-15 | 115 |
| K040207 | EP-4 CLINICAL STIMULATOR | JOQ | 2004-02-27 | 28 |
| K031066 | VIEWMATE ULTRASOUND IMAGING SYSTEM | IYN | 2003-10-17 | 197 |
5 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2006-04-04.
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.
Device clinical trials
An industry sponsor named Ep Medsystems is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00281073: Intra-Cardiac Echocardiography Guided Cardioversion(ICE-CHIP) Study (Completed, started 2005-03)
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Ep Medsystems (12)
- Ep Medsystems, Inc. (3)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ep Medsystems?
FDA lists 15 510(k) clearances under 2 spellings of the applicant name “Ep Medsystems” (first 1996, latest 2009), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ep Medsystems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ep Medsystems is 30 days.
Which FDA product codes appear under Ep Medsystems?
The most frequent FDA product codes under this applicant name are DQK (Computer, Diagnostic, Programmable, 5); DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording, 3); JOQ (Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only), 3).
Next steps
- See all 15 Ep Medsystems clearances with predicates and recalls
- Run predicate analysis for product code DQK, Ep Medsystems'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.