Cleared Traditional

K905102 - BARD(R) SYRINGE ASSIST IRRIGATION

K905102 is an FDA 510(k) clearance for BARD SYRINGE ASSIST IRRIGATION, manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCX cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K905102 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Apr 1991
Decision
147d
Days
Class 2
Risk

K905102 is an FDA 510(k) clearance for the BARD(R) SYRINGE ASSIST IRRIGATION. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on April 9, 1991 after a review of 147 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K905102

510(k) Number K905102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1990
Decision Date April 09, 1991
Days to Decision 147 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 131d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCX Device Classification - Class 2, Special Controls

Product Code OCX Endoscopic Irrigation/suction System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.
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 - OCX Endoscopic Irrigation/suction System

All 92
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K905102.
TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER
K942918 · Tri-Med Specialties, Inc. · Feb 1995
ENDOMEDIX Y-ADAPTER
K934170 · Endomedix · Jan 1994
TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER
K931201 · Tri-Med Specialties, Inc. · Sep 1993
N. M. BEALE COMPANY VU-THRU WATER BOTTLE
K903834 · N.M. Beale Co., Inc. · Sep 1990
NO. 86500 - ENDOSCOPIC JET WASHER
K892426 · Superior Healthcare Group, Inc. · Jun 1989
IRRI-FLO IRRIGATION DELIVERY SYSTEM
K891339 · Surgitek · Jun 1989
K905102 · BARD(R) SYRINGE ASSIST IRRIGATION
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