Cleared Traditional

URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450 (K882714) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K882714 · Lsl Industries, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1989
Decision
214d
Days
Class 1
Risk

K882714 is an FDA 510(k) clearance for the URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450. Classified as System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile (product code EYZ), Class I - General Controls.

Submitted by Lsl Industries, Inc. (Chicago, US). The FDA issued a Cleared decision on January 31, 1989 after a review of 214 days - an extended review cycle.

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 Lsl Industries, Inc. devices

Submission Details

510(k) Number K882714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1988
Decision Date January 31, 1989
Days to Decision 214 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
84d slower than avg
Panel avg: 130d · This submission: 214d
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.