Cleared Traditional

K780267 - CATH TRAY W/OUT CATHETER

K780267 is an FDA 510(k) clearance for CATH TRAY W/OUT CATHETER, manufactured by Latex Ind., Inc.. The device is a Class 1 Gastroenterology & Urology device with product code EYZ cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K780267 · Latex Ind., Inc. · Gastroenterology & Urology device
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Feb 1978
Decision
7d
Days
Class 1
Risk

K780267 is an FDA 510(k) clearance for the CATH TRAY W/OUT CATHETER. Classified as System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile (product code EYZ), Class I - General Controls.

Submitted by Latex Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on February 24, 1978 after a review of 7 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K780267

510(k) Number K780267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1978
Decision Date February 24, 1978
Days to Decision 7 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
124d faster than avg
Panel avg: 131d · This submission: 7d
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 10
Devices cleared under the same product code (EYZ) and FDA review panel - the closest regulatory comparables to K780267.
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