Cleared Traditional

K052929 - PREFTEST PROFESSIONAL SUITE

K052929 · Limestone Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
189d
Days
-
Risk

K052929 is an FDA 510(k) clearance for the PREFTEST PROFESSIONAL SUITE. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Limestone Technologies, Inc. (Dundas, CA). The FDA issued a Cleared decision on April 26, 2006 after a review of 189 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Limestone Technologies, Inc. devices

FDA 510(k) Submission Details - K052929

510(k) Number K052929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2005
Decision Date April 26, 2006
Days to Decision 189 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 131d · This submission: 189d
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 K052929.
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K000194 · Uroan Xxi Electromedicina · Apr 2000
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