Cleared Traditional

DUAL FLEX NON-LATEX (K905026) - FDA 510(k) Clearance

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

K905026 · Mmi, Inc. · Gastroenterology & Urology device
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Dec 1991
Decision
406d
Days
Class 2
Risk

K905026 is an FDA 510(k) clearance for the DUAL FLEX NON-LATEX. Classified as Catheter, Retention, Barium Enema With Bag (product code FGD), Class II - Special Controls.

Submitted by Mmi, Inc. (Southfield, US). The FDA issued a Cleared decision on December 18, 1991 after a review of 406 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Mmi, Inc. devices

Submission Details

510(k) Number K905026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1990
Decision Date December 18, 1991
Days to Decision 406 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
276d slower than avg
Panel avg: 130d · This submission: 406d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.