Cleared Traditional

URINARY DRAINAGE BAG (K951597) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K951597 · Key Medical Services, Inc. · Gastroenterology & Urology device
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Aug 1995
Decision
119d
Days
Class 1
Risk

K951597 is an FDA 510(k) clearance for the URINARY DRAINAGE BAG. Classified as System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile (product code EYZ), Class I - General Controls.

Submitted by Key Medical Services, Inc. (Chicago, US). The FDA issued a Cleared decision on August 4, 1995 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5250 - 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 Key Medical Services, Inc. devices

Submission Details

510(k) Number K951597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1995
Decision Date August 04, 1995
Days to Decision 119 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
11d faster than avg
Panel avg: 130d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EYZ System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5250
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.