Cleared Traditional

K901000 - URO TEX URINALS

K901000 is an FDA 510(k) clearance for URO TEX URINALS, manufactured by Sierra Laboratories, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code EYZ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K901000 · Sierra Laboratories, Inc. · Gastroenterology & Urology device
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Mar 1990
Decision
24d
Days
Class 1
Risk

K901000 is an FDA 510(k) clearance for the URO TEX URINALS. Classified as System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile (product code EYZ), Class I - General Controls.

Submitted by Sierra Laboratories, Inc. (Tucson, US). The FDA issued a Cleared decision on March 26, 1990 after a review of 24 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.

View all Sierra Laboratories, Inc. devices

FDA 510(k) Submission Details - K901000

510(k) Number K901000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1990
Decision Date March 26, 1990
Days to Decision 24 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
107d faster than avg
Panel avg: 131d · This submission: 24d
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 K901000.
ZIP CONDOM CATHETER
K964219 · Goulter Medical, Inc. · Aug 1997
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K891178 · Tecnol New Jersey Wound Care, Inc. · May 1989
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K772113 · Travenol Laboratories, S.A. · Nov 1977