510(k) Report

FDA applicant

Revive Systems Corp.

Washington, DC1 decision1985–19850 recalls

FDA records 1 decision for Revive Systems Corp. (Washington, DC) in 1985: 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 Revive Systems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Revive Systems Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Revive Systems Corp. 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 2 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.

  • K844445Revive SystemRevive Systems Corp. · 19852cite it

What has FDA decided for it lately?

  • K844445Revive SystemRevive Systems Corp. · 1985

The one decision as Revive Systems Corp. →