Cleared Traditional

CAT-600 PENILE PLETHYSMOGRAPH (K936115) - FDA 510(k) Clearance

K936115 · Farrall Instruments, Inc. · Gastroenterology & Urology device
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Jan 1995
Decision
690d
Days
-
Risk

K936115 is an FDA 510(k) clearance for the CAT-600 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 690 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Farrall Instruments, Inc. devices

Submission Details

510(k) Number K936115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1993
Decision Date January 10, 1995
Days to Decision 690 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
560d slower than avg
Panel avg: 130d · This submission: 690d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIL Monitor, Penile Tumescence
Device Class -