510(k) Report

FDA applicant

Nu-Potent

Augusta, GA1 decision1984–19840 recalls

FDA records 1 decision for Nu-Potent (Augusta, GA) in 1984: 1 510(k) clearance. All are in product code LKY (Device, External Penile Rigidity). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Nu-Potent’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nu-Potent since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nu-Potent 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?

  • LKYDevice, External Penile Rigidity1decision

Who builds on its devices?

Later devices cite its devices 8 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.

  • K841257Sta-Potent SystemNu-Potent · 19848cite it

What has FDA decided for it lately?

  • K841257Sta-Potent SystemNu-Potent · 1984

The one decision as Nu-Potent →