Cleared Special

K033126 - MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM

K033126 · Behavioral Technology, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
29d
Days
-
Risk

K033126 is an FDA 510(k) clearance for the MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Behavioral Technology, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 29, 2003 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Behavioral Technology, Inc. devices

FDA 510(k) Submission Details - K033126

510(k) Number K033126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date October 29, 2003
Days to Decision 29 days
Submission Type Special
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
102d faster than avg
Panel avg: 131d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

LIL Device Classification - Class 0,

Product Code LIL Monitor, Penile Tumescence
Device Class -

Regulatory Peers - LIL Monitor, Penile Tumescence

All 15
Devices cleared under the same product code (LIL) and FDA review panel - the closest regulatory comparables to K033126.
RIGIDOMETER, MODEL DIR-4U
K061676 · Uroan 21 · Dec 2006
PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)
K062042 · Plethora Solutions · Sep 2006
PREFTEST PROFESSIONAL SUITE
K052929 · Limestone Technologies, Inc. · Apr 2006
DIGITAL INFLECTION RIGIDOMETER (DIR)
K000194 · Uroan Xxi Electromedicina · Apr 2000
VISER PENILE TUMESCENCE MONITOR
K991479 · Laborie Medical Tech Corp. · Jul 1999
NEVA SYSTEM
K980627 · Urometrics, Inc. · Apr 1998