Cleared Traditional

K940128 - CAT-400UL PENILE PLETHYSMOGRAPH

K940128 · Farrall Instruments, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Farrall Instruments, Inc. devices

FDA 510(k) Submission Details - K940128

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
234d slower than avg
Panel avg: 131d · This submission: 365d
Pathway characteristics
Predicate-based equivalence.

LIL Device Classification - Class 0,

Product Code LIL Monitor, Penile Tumescence
Device Class -

Regulatory Peers - LIL Monitor, Penile Tumescence

All 13
Devices cleared under the same product code (LIL) and FDA review panel - the closest regulatory comparables to K940128.
PREFTEST PROFESSIONAL SUITE
K052929 · Limestone Technologies, Inc. · Apr 2006
VISER PENILE TUMESCENCE MONITOR
K991479 · Laborie Medical Tech Corp. · Jul 1999
NEVA SYSTEM
K980627 · Urometrics, Inc. · Apr 1998
RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM
K941781 · Dacomed Corp. · Aug 1994
BARD (R) ESKA ERECTIOMETER
K880903 · C.R. Bard, Inc. · May 1988
SURGITEK NPT MONITOR
K875333 · Surgitek · Apr 1988