Cleared Traditional

K953640 - DUNA II PENILE PROSTHESIS

K953640 is the FDA 510(k) clearance for DUNA II PENILE PROSTHESIS by Dacomed Corp.. It is a Class 2 Gastroenterology & Urology device (product code FAE) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K953640 · Dacomed Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
84d
Days
Class 2
Risk

K953640 is an FDA 510(k) clearance for the DUNA II PENILE PROSTHESIS. Classified as Prosthesis, Penile (product code FAE), Class II - Special Controls.

Submitted by Dacomed Corp. (Minneapolis, US). The FDA issued a Cleared decision on October 27, 1995 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.3630 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dacomed Corp. devices

Submission Details

510(k) Number K953640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1995
Decision Date October 27, 1995
Days to Decision 84 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 130d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAE Prosthesis, Penile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.3630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FAE Prosthesis, Penile

All 19
Devices cleared under the same product code (FAE) and FDA review panel - the closest regulatory comparables to K953640.
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
K082006 · American Medical Systems, Inc. · Oct 2008
MENTOR GENESIS PENILE PROSTHESIS
K040959 · Mentor Corp. · Oct 2004
AMS AMBICOR PENILE PROSTHESIS
K963328 · American Medical Systems, Inc. · Dec 1996
AMS 650 MALLERABLE PENIEL PROSTHESIS
K951716 · American Medical Systems, Inc. · Jul 1995
AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
K912935 · American Medical Systems, Inc. · Mar 1992
MENTOR MODIFIED MALLEABLE PENILE PROSTHESES
K900371 · Mentor Corp. · Nov 1990