510(k) Report

FDA applicant

Nikomed U.S.A., Inc.

Doylestown, PA15 decisions1987–20032 recalls

FDA records 15 decisions for Nikomed U.S.A., Inc. (Doylestown, PA) from 1987 to 2003: 15 510(k) clearances. Most are in product codes DRX (Electrode, Electrocardiograph) and HAM (Apparatus, Electrosurgical). 2 recalls are linked to its devices.

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 Nikomed U.S.A., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nikomed U.S.A., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nikomed U.S.A., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DRXElectrode, Electrocardiograph12decisions
  • HAMApparatus, Electrosurgical1decision
  • LDDDc-Defibrillator, Low-Energy, (Including Paddles)1decision
  • CBHDevice, Fixation, Tracheal Tube1decision

Who builds on its devices?

Later devices cite its devices 13 times; 0 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.

  • K000079Nikopad Electrosurgical Grounding Pad, Model 4777MNikomed U.S.A., Inc. · 20003cite it
  • K950476Disposable Ecg Monitoring Electrode #4440 60MM, #4420 40MMNikomed U.S.A., Inc. · 19951cites it
  • K950478Disposable Ecg Monitoring Electrode #4570 38X60MMNikomed U.S.A., Inc. · 19951cites it
  • K950474Disposable Ecg Monitoring Electrode #4533 32X45MMNikomed U.S.A., Inc. · 19951cites it
  • K950473Disposable Ecg Monitoring ElectrodeNikomed U.S.A., Inc. · 19951cites it
  • K950479Disposable Ecg Monitoring Electrode #4600 60MM, #4610 45MMNikomed U.S.A., Inc. · 19951cites it

What has FDA decided for it lately?

  • K022909Nikomed Trace 1 Ecg ElectrodesNikomed U.S.A., Inc. · 2003
  • K000079Nikopad Electrosurgical Grounding Pad, Model 4777MNikomed U.S.A., Inc. · 20002 recalls
  • K950473Disposable Ecg Monitoring ElectrodeNikomed U.S.A., Inc. · 1995
  • K950475Disposable Ecg Monitoring Electrode #4530, #4540Nikomed U.S.A., Inc. · 1995
  • K950472Disposable Ecg Monitoring Electrode #4110 45MM, #4140 35MMNikomed U.S.A., Inc. · 1995
  • K950478Disposable Ecg Monitoring Electrode #4570 38X60MMNikomed U.S.A., Inc. · 1995
  • K950474Disposable Ecg Monitoring Electrode #4533 32X45MMNikomed U.S.A., Inc. · 1995
  • K950471Disposable Ecg Monitoring Electrode #4580 32X45MMNikomed U.S.A., Inc. · 1995

All 15 as Nikomed U.S.A., Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K000079Radionics Cool-Tip RF Electrode Kit, containing DGP-HP single-use grounding pads.Jul 16, 2003
  • K000079Radionics Disposable Grounding PlateJul 16, 2003