Cleared Traditional

K905574 - SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF

K905574 is an FDA 510(k) clearance for SLIM LINE RETENTION TIP W/ SILICONE RUB..., manufactured by E-Z-Em, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGD cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K905574 · E-Z-Em, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jan 1991
Decision
43d
Days
Class 2
Risk

K905574 is an FDA 510(k) clearance for the SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF. Classified as Catheter, Retention, Barium Enema With Bag (product code FGD), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Worcester, US). The FDA issued a Cleared decision on January 24, 1991 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 - K905574

510(k) Number K905574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1990
Decision Date January 24, 1991
Days to Decision 43 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
88d faster than avg
Panel avg: 131d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGD Device Classification - Class 2, Special Controls

Product Code FGD Catheter, Retention, Barium Enema With Bag
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - FGD Catheter, Retention, Barium Enema With Bag

Devices cleared under the same product code (FGD) and FDA review panel - the closest regulatory comparables to K905574.
NAJA Gastrointestinal Catheter
K223890 · Chess Medical, Inc. · Jun 2023
DUAL FLEX NON-LATEX
K905026 · Mmi, Inc. · Dec 1991
SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF
K904299 · E-Z-Em, Inc. · Nov 1990
MAGLINTE ENTEROCLYSIS CATHETER
K884379 · Lafayette Pharmacal, Inc. · Feb 1989
DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF
K872006 · Mac Lee Medical Products · Nov 1987
K905574 · SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF
Download PDF E-Z-Em, Inc.