Cleared Traditional

K974470 - VTU-E VACUUM ERECTION SYSTEM

K974470 is an FDA 510(k) clearance for VTU-E VACUUM ERECTION SYSTEM, manufactured by Encore, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LKY cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K974470 · Encore, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
44d
Days
Class 2
Risk

K974470 is an FDA 510(k) clearance for the VTU-E VACUUM ERECTION SYSTEM. Classified as Device, External Penile Rigidity (product code LKY), Class II - Special Controls.

Submitted by Encore, Inc. (Washington, US). The FDA issued a Cleared decision on January 9, 1998 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5020 - 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 Encore, Inc. devices

FDA 510(k) Submission Details - K974470

510(k) Number K974470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1997
Decision Date January 09, 1998
Days to Decision 44 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
87d faster than avg
Panel avg: 131d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKY Device Classification - Class 2, Special Controls

Product Code LKY Device, External Penile Rigidity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5020
Definition Intended To Create Or Maintain Sufficient Penile Rigidity For Sexual Intercourse. These Include Vacuum Pumps, Constriction Rings, And Penile Splints, Which Are Mechanical, Powered Or Pneumatic Devices.
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 - LKY Device, External Penile Rigidity

All 42
Devices cleared under the same product code (LKY) and FDA review panel - the closest regulatory comparables to K974470.
THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER DEVICE
K974082 · Performance Plus, Inc. · Feb 1998
ERECAID SYSTEM/STAY EREC SYSTEM
K974173 · Imagyn Medical Technologies, Inc. · Feb 1998
VET-CO OTC VACUUM DEVICE/VET-CO CONSTRICTION RING SET
K974215 · Vetco, Inc. · Feb 1998
ERCO-VAC
K972537 · Ercons, Inc. · Nov 1997
ERCO-RIBBON
K972353 · Ercons, Inc. · Oct 1997
REJOYN PENILE SUPPORT SYSTEM
K971576 · American Medtech · Oct 1997