Cleared Traditional

THE BOOSTER (K860698) - FDA 510(k) Clearance

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

K860698 · Knapps Corp. · Gastroenterology & Urology device
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Feb 1989
Decision
1074d
Days
Class 2
Risk

K860698 is an FDA 510(k) clearance for the THE BOOSTER. Classified as Device, External Penile Rigidity (product code LKY), Class II - Special Controls.

Submitted by Knapps Corp. (Newark, US). The FDA issued a Cleared decision on February 3, 1989 after a review of 1074 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Knapps Corp. devices

Submission Details

510(k) Number K860698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1986
Decision Date February 03, 1989
Days to Decision 1074 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
944d slower than avg
Panel avg: 130d · This submission: 1074d
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.