Cleared Traditional

CMI E-Z FLO BULB P.N. 701 (K932128) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K932128 · Columbia Medical & Surgical, Inc. · Gastroenterology & Urology device
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Apr 1994
Decision
339d
Days
Class 1
Risk

K932128 is an FDA 510(k) clearance for the CMI E-Z FLO BULB P.N. 701. Classified as Adaptor, Bulbs, Miscellaneous, For Endoscope (product code FFY), Class I - General Controls.

Submitted by Columbia Medical & Surgical, Inc. (Bend, US). The FDA issued a Cleared decision on April 7, 1994 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K932128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1993
Decision Date April 07, 1994
Days to Decision 339 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
209d slower than avg
Panel avg: 130d · This submission: 339d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FFY Adaptor, Bulbs, Miscellaneous, For Endoscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1500
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.