Cleared Traditional

PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) (K062042) - FDA 510(k) Clearance

K062042 · Plethora Solutions · Gastroenterology & Urology device
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Sep 2006
Decision
49d
Days
-
Risk

K062042 is an FDA 510(k) clearance for the PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM). Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Plethora Solutions (Lexington, US). The FDA issued a Cleared decision on September 6, 2006 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K062042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2006
Decision Date September 06, 2006
Days to Decision 49 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 130d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIL Monitor, Penile Tumescence
Device Class -