Cleared Traditional

CAT-400UL PENILE PLETHYSMOGRAPH (K940128) - FDA 510(k) Clearance

K940128 · Farrall Instruments, Inc. · Gastroenterology & Urology device
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Jan 1995
Decision
365d
Days
-
Risk

K940128 is an FDA 510(k) clearance for the CAT-400UL PENILE PLETHYSMOGRAPH. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Farrall Instruments, Inc. (Grand Island, US). The FDA issued a Cleared decision on January 10, 1995 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K940128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1994
Decision Date January 10, 1995
Days to Decision 365 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
235d slower than avg
Panel avg: 130d · This submission: 365d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIL Monitor, Penile Tumescence
Device Class -