510(k) Report

FDA applicant

Plethora Solutions

Lexington, MA1 decision2006–20060 recalls

FDA records 1 decision for Plethora Solutions (Lexington, MA) in 2006: 1 510(k) clearance. All are in product code LIL (Monitor, Penile Tumescence). Its devices cite 2 predicates, 0 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

How often FDA has decided Plethora Solutions’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Plethora Solutions since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Plethora Solutions 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?

  • LILMonitor, Penile Tumescence1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K062042Plethora Solutions Sexual Assessment Monitor (Sam)Plethora Solutions · 2006

The one decision as Plethora Solutions →