Cleared Traditional

CONSTRICTOR RING FOR PENILE ERECTION (K891125) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K891125 · Performance, Inc. · Gastroenterology & Urology device
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Apr 1989
Decision
55d
Days
Class 2
Risk

K891125 is an FDA 510(k) clearance for the CONSTRICTOR RING FOR PENILE ERECTION. Classified as Device, External Penile Rigidity (product code LKY), Class II - Special Controls.

Submitted by Performance, Inc. (Great Neck, US). The FDA issued a Cleared decision on April 27, 1989 after a review of 55 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 Performance, Inc. devices

Submission Details

510(k) Number K891125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1989
Decision Date April 27, 1989
Days to Decision 55 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 130d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.