510(k) Report

FDA applicant

Ep Medsystems

West Berlin, NJ15 decisions1996–20093 recalls

FDA records 15 decisions for Ep Medsystems (West Berlin, NJ) from 1996 to 2009: 15 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and DRF (Catheter, Electrode Recording, Or Probe…). Its devices cite 16 predicates, 7 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Ep Medsystems, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Ep Medsystems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 22008: 12009: 1
2007high 2 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2009

2009: 2
2007high 2 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ep Medsystems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ep Medsystems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DQKComputer, Diagnostic, Programmable5decisions
  • DRFCatheter, Electrode Recording, Or Probe, Electrode Recording3decisions
  • JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)3decisions
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2decisions
  • DYBIntroducer, Catheter1decision
  • ITNSplint, Denis Brown1decision

Whose devices does it build on?

Its devices cite 16 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K031066Viewmate Ultrasound Imaging SystemEp Medsystems · 20035cite it
  • K994011EP Medsystems, EP-WorkmateEp Medsystems, Inc. · 20003cite it
  • K033963EP Deflectable CathetersEp Medsystems, Inc. · 20041cites it
  • K063277MapmateEp Medsystems, Inc. · 20061cites it
  • K071028Viewmate SystemEp Medsystems · 20071cites it
  • K073709Modification to Viewmate SystemEp Medsystems · 20081cites it

What has FDA decided for it lately?

  • K092913EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04Ep Medsystems · 2009
  • K073709Modification to Viewmate SystemEp Medsystems · 2008
  • K071028Viewmate SystemEp Medsystems · 2007
  • K070706EP-WorkmateEp Medsystems · 20071 recall
  • K063277MapmateEp Medsystems, Inc. · 2006
  • K063113EP-WorkmateEp Medsystems · 2006
  • K041442EP-4 Clinical StimutatorEp Medsystems · 20041 recall
  • K033963EP Deflectable CathetersEp Medsystems, Inc. · 2004

All 12 as Ep Medsystems →All 3 as Ep Medsystems, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K040207EP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 / 09-1527-0002; EP…Mar 23, 2009
  • K070706NurseMate with Physio Module; Remote Review, Monitoring and Charting Station; USA…Feb 13, 2009
  • K040207EP-4 Computerized Stimulator -- 2 channel and 4 channel. The product consists of a…Apr 4, 2006