510(k) Report

FDA applicant

Mckenna & Cuneo

Washington, DC3 decisions1995–19971 recall

FDA records 3 decisions for Mckenna & Cuneo (Washington, DC) from 1995 to 1997: 3 510(k) clearances. Most are in product codes GWF (Stimulator, Electrical, Evoked Response) and LKY (Device, External Penile Rigidity). 1 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, neurology panel, where it files most

How often FDA has decided Mckenna & Cuneo’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mckenna & Cuneo since 2007.

Recalls per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Mckenna & Cuneo 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?

  • GWFStimulator, Electrical, Evoked Response1decision
  • LKYDevice, External Penile Rigidity1decision
  • LYGMassager, Therapeutic, Manual1decision

Who builds on its devices?

Later devices cite its devices 5 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.

  • K944547Dantec KeypointMckenna & Cuneo · 19954cite it
  • K971257Vtu-1 Vacuum Erection SystemMckenna & Cuneo · 19971cites it

What has FDA decided for it lately?

  • K971257Vtu-1 Vacuum Erection SystemMckenna & Cuneo · 1997
  • K936312Manual Massage RollerMckenna & Cuneo · 1996
  • K944547Dantec KeypointMckenna & Cuneo · 19951 recall

All 3 as Mckenna & Cuneo →

What has been recalled?

1 recall linked to its devices; the latest:

  • K944547Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103…Apr 9, 2013Class II