Cleared Traditional

K864448 - THE BIOSONICS CONTINENCE CONTROL SYSTEM...

K864448 is an FDA 510(k) clearance for THE BIOSONICS CONTINENCE CONTROL SYSTEM..., manufactured by Biosonics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPN cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K864448 · Biosonics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
86d
Days
Class 2
Risk

K864448 is an FDA 510(k) clearance for the THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM). Classified as Alarm, Conditioned Response Enuresis (product code KPN), Class II - Special Controls.

Submitted by Biosonics, Inc. (Philadelphia, US). The FDA issued a Cleared decision on February 6, 1987 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.2040 - 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 Biosonics, Inc. devices

FDA 510(k) Submission Details - K864448

510(k) Number K864448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date February 06, 1987
Days to Decision 86 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
44d faster than avg
Panel avg: 130d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPN Device Classification - Class 2, Special Controls

Product Code KPN Alarm, Conditioned Response Enuresis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.2040
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.