Cleared Traditional

ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY (K904158) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904158 · Welcon, Inc. · Gastroenterology & Urology device
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Nov 1990
Decision
83d
Days
Class 2
Risk

K904158 is an FDA 510(k) clearance for the ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY. Classified as Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (product code FCM), Class II - Special Controls.

Submitted by Welcon, Inc. (Providence, US). The FDA issued a Cleared decision on November 29, 1990 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Welcon, Inc. devices

Submission Details

510(k) Number K904158 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received September 07, 1990
Decision Date November 29, 1990
Days to Decision 83 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
47d faster than avg
Panel avg: 130d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)

All 59
Devices cleared under the same product code (FCM) and FDA review panel - the closest regulatory comparables to K904158.
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TOUCHLESS II INTERMITTENT CATHETER
K910653 · C.R. Bard, Inc. · May 1991