510(k) Report

FDA applicant

Niko Medical Products

Fort Worth, TX1 decision2001–20010 recalls

FDA records 1 decision for Niko Medical Products (Fort Worth, TX) in 2001: 1 510(k) clearance. All are in product code DRX (Electrode, Electrocardiograph). No recall is 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 Niko Medical Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Niko Medical Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Niko Medical Products 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, Electrocardiograph1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K003804Sensi-Prema Neonatal Ecg Electrodes, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801Niko Medical Products · 20011cites it

What has FDA decided for it lately?

  • K003804Sensi-Prema Neonatal Ecg Electrodes, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801Niko Medical Products · 2001

The one decision as Niko Medical Products →

Other applicant names beginning “Niko”

FDA records each applicant name separately; these may or may not be the same firm.

Niko Sunglasses Corp. 1