Cleared Traditional

K882714 - URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450

K882714 is an FDA 510(k) clearance for URINARY DRAIN BAG, manufactured by Lsl Industries, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code EYZ cleared through the Traditional 510(k) pathway after a 214-day FDA review.

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

FDA 510(k) Submission Details - K882714

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
83d slower than avg
Panel avg: 131d · This submission: 214d
Pathway characteristics
Predicate-based equivalence.

EYZ Device Classification - Class 1, General Controls

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.

Regulatory Peers - EYZ System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile

Devices cleared under the same product code (EYZ) and FDA review panel - the closest regulatory comparables to K882714.
DYNA-FLO URINARY DRAINAGE BAG
K896695 · Medline Industries, Inc. · May 1990
CLOSED SYSTEM URINARY DRAINAGE BAG
K890465 · Cypress Medical Products, Ltd. · May 1989
TECNOL SECURE-ALL TUBE HOLDER
K891178 · Tecnol New Jersey Wound Care, Inc. · May 1989
URINARY DRAINAGE BAG 2D9017
K772113 · Travenol Laboratories, S.A. · Nov 1977