Cleared Special

K100803 - OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K100803 · Keymed, Inc. · Gastroenterology & Urology device
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Apr 2010
Decision
31d
Days
Class 2
Risk

K100803 is an FDA 510(k) clearance for the OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1. Classified as Pump, Air, Non-manual, For Endoscope (product code FEQ), Class II - Special Controls.

Submitted by Keymed, Inc. (San Diego, US). The FDA issued a Cleared decision on April 22, 2010 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Keymed, Inc. devices

Submission Details

510(k) Number K100803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2010
Decision Date April 22, 2010
Days to Decision 31 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 130d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

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.