Cleared Traditional

K930581 - E-Z-FLATE (FDA 510(k) Clearance)

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

K930581 · E-Z-Em, Inc. · Gastroenterology & Urology device
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Jul 1994
Decision
512d
Days
Class 2
Risk

K930581 is an FDA 510(k) clearance for the E-Z-FLATE. Classified as Insufflator, Automatic Carbon-dioxide For Endoscope (product code FCX), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on July 1, 1994 after a review of 512 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: 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 E-Z-Em, Inc. devices

Submission Details

510(k) Number K930581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1993
Decision Date July 01, 1994
Days to Decision 512 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
382d slower than avg
Panel avg: 130d · This submission: 512d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FCX Insufflator, Automatic Carbon-dioxide For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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.