510(k) Report

FDA applicant

Neptec Design Group, Ltd.

Chapel Hill, NC4 decisions2001–20030 recalls

FDA records 4 decisions for Neptec Design Group, Ltd. (Chapel Hill, NC) from 2001 to 2003: 4 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and DRG (Transmitters And Receivers, Physiological…). Its devices cite 11 predicates, 2 of them its own earlier devices. 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 Neptec Design Group, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neptec Design Group, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Neptec Design Group, Ltd. 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?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive3decisions
  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency1decision

Whose devices does it build on?

Its devices cite 11 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 2 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.

  • K020584N2000 Base Station; N2001 Nurse StationNeptec Design Group, Ltd. · 20023cite it
  • K022274Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 20032cite it
  • K012801N2000 Base Station, N2001 Nurse StationNeptec Design Group, Ltd. · 20011cites it
  • K023286Carecompanion Patient Station/Carecompanion Patient StationNeptec Design Group, Ltd. · 20031cites it

What has FDA decided for it lately?

  • K022274Carecompanion Patient Station & Nurse StationNeptec Design Group, Ltd. · 2003
  • K023286Carecompanion Patient Station/Carecompanion Patient StationNeptec Design Group, Ltd. · 2003
  • K020584N2000 Base Station; N2001 Nurse StationNeptec Design Group, Ltd. · 2002
  • K012801N2000 Base Station, N2001 Nurse StationNeptec Design Group, Ltd. · 2001

All 4 as Neptec Design Group, Ltd. →