Cleared Traditional

DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM (K950784) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K950784 · Advanced Bioresearch Assoc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
71d
Days
Class 1
Risk

K950784 is an FDA 510(k) clearance for the DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM. Classified as Garment, Protective, For Incontinence (product code EYQ), Class I - General Controls.

Submitted by Advanced Bioresearch Assoc. (Rockville, US). The FDA issued a Cleared decision on May 3, 1995 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5920 - 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 Advanced Bioresearch Assoc. devices

Submission Details

510(k) Number K950784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1995
Decision Date May 03, 1995
Days to Decision 71 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 130d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EYQ Garment, Protective, For Incontinence
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5920
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.