Cleared Traditional

RT2 RIGIDITY AND TUMESCENCE TEST (K925931) - FDA 510(k) Clearance

K925931 · Compass Medical Technologies, Inc. · Gastroenterology & Urology device
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Dec 1992
Decision
28d
Days
-
Risk

K925931 is an FDA 510(k) clearance for the RT2 RIGIDITY AND TUMESCENCE TEST. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Compass Medical Technologies, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 21, 1992 after a review of 28 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.

View all Compass Medical Technologies, Inc. devices

Submission Details

510(k) Number K925931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1992
Decision Date December 21, 1992
Days to Decision 28 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIL Monitor, Penile Tumescence
Device Class -