Cleared Traditional

K100899 - OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2 (FDA 510(k) Clearance)

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

K100899 · Keymed (Medical & Industrial Equipment), Ltd. · Gastroenterology & Urology device
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Sep 2010
Decision
166d
Days
Class 2
Risk

K100899 is an FDA 510(k) clearance for the OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2. Classified as Pump, Air, Non-manual, For Endoscope (product code FEQ), Class II - Special Controls.

Submitted by Keymed (Medical & Industrial Equipment), Ltd. (San Diego, US). The FDA issued a Cleared decision on September 13, 2010 after a review of 166 days - an extended review cycle.

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. Standard predicate reliance. 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.

View all Keymed (Medical & Industrial Equipment), Ltd. devices

Submission Details

510(k) Number K100899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2010
Decision Date September 13, 2010
Days to Decision 166 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 130d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FEQ Pump, Air, Non-manual, 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.