Cleared Traditional

K862683 - BIOSOICS SPHINCTER TRAINING SYSTEM

K862683 is an FDA 510(k) clearance for BIOSOICS SPHINCTER TRAINING 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 120-day FDA review.

K862683 · Biosonics, Inc. · Gastroenterology & Urology device
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Nov 1986
Decision
120d
Days
Class 2
Risk

K862683 is an FDA 510(k) clearance for the BIOSOICS SPHINCTER TRAINING SYSTEM. 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 November 12, 1986 after a review of 120 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosonics, Inc. devices

FDA 510(k) Submission Details - K862683

510(k) Number K862683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1986
Decision Date November 12, 1986
Days to Decision 120 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
10d faster than avg
Panel avg: 130d · This submission: 120d
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.