Cleared Traditional

K100899 - OLYMPUS ENDOSCOPIC FLUSHING PUMP

K100899 is an FDA 510(k) clearance for OLYMPUS ENDOSCOPIC FLUSHING PUMP, manufactured by Keymed (Medical & Industrial Equipment), Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FEQ cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K100899 · Keymed (Medical & Industrial Equipment), Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K100899

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.

FEQ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FEQ Pump, Air, Non-manual, For Endoscope

All 17
Devices cleared under the same product code (FEQ) and FDA review panel - the closest regulatory comparables to K100899.
AQUASHIELD CO2 SYSTEM
K120123 · United States Endoscopy Group, Inc. · Mar 2012
ENDOCHOICE WATER BOTTLE CAP SYSTEM
K112576 · Endochoice, Inc. · Jan 2012
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES
K103696 · Erbe USA, Inc. · Mar 2011
WATER BOTTLE CAP SYSTEM
K101146 · United States Endoscopy Group, Inc. · Jul 2010
OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1
K100803 · Keymed, Inc. · Apr 2010