Cleared Traditional

K896695 - DYNA-FLO URINARY DRAINAGE BAG

K896695 is an FDA 510(k) clearance for DYNA-FLO URINARY DRAINAGE BAG, manufactured by Medline Industries, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code EYZ cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K896695 · Medline Industries, Inc. · Gastroenterology & Urology device
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May 1990
Decision
155d
Days
Class 1
Risk

K896695 is an FDA 510(k) clearance for the DYNA-FLO URINARY DRAINAGE BAG. Classified as System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile (product code EYZ), Class I - General Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on May 2, 1990 after a review of 155 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.

FDA 510(k) Submission Details - K896695

510(k) Number K896695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1989
Decision Date May 02, 1990
Days to Decision 155 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 131d · This submission: 155d
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

All 13
Devices cleared under the same product code (EYZ) and FDA review panel - the closest regulatory comparables to K896695.
ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER
K942753 · Researched, Novel Medical Devices (Rn/Md) · Nov 1994
COMFORTCARE SYSTEM
K933126 · Patsy J. Trisler, J.D. · Feb 1994
NIGHT URINARY DRAINAGE BEDSIDE BAG
K930556 · Ezmt Valve Co., Inc. · May 1993
URO TEX URINALS
K901000 · Sierra Laboratories, Inc. · Mar 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
K896695 · DYNA-FLO URINARY DRAINAGE BAG
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