Cleared Traditional

PERITONE DISPOSAL SHEATH - RUBBER AND VINYL (K860552) - FDA 510(k) Clearance

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

K860552 · Laurie Ann Kaiser, Ph.D. · Gastroenterology & Urology device
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Apr 1986
Decision
62d
Days
Class 2
Risk

K860552 is an FDA 510(k) clearance for the PERITONE DISPOSAL SHEATH - RUBBER AND VINYL. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Laurie Ann Kaiser, Ph.D. (Bellerose, US). The FDA issued a Cleared decision on April 17, 1986 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 884.1425 - 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 Laurie Ann Kaiser, Ph.D. devices

Submission Details

510(k) Number K860552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1986
Decision Date April 17, 1986
Days to Decision 62 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
68d faster than avg
Panel avg: 130d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIR Perineometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1425
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.