Cleared Traditional

K142068 - BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON

Also marketed or referenced as:
PENTAX COMPATIBLE DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE

K142068 is an FDA 510(k) clearance for BULLDOG BIOPSY VALVE, manufactured by Medovations, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCX cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K142068 · Medovations, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
223d
Days
Class 2
Risk

K142068 is an FDA 510(k) clearance for the BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Medovations, Inc. (Milwaukee, US). The FDA issued a Cleared decision on March 10, 2015 after a review of 223 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 Medovations, Inc. devices

FDA 510(k) Submission Details - K142068

510(k) Number K142068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2014
Decision Date March 10, 2015
Days to Decision 223 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 131d · This submission: 223d
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 81
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K142068.
Seal Single-Use Biopsy Valve
K161167 · Endochoice, Inc. · May 2016
ENDOFLOW II - Irrigation, Warming and Suction System
K152278 · Promepla Sam · Feb 2016
Boa Endoscopic Valve
K152140 · C2 Therapeutics, Inc. · Oct 2015
Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector
K143186 · Erbe USA, Inc. · Dec 2014
ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM
K140753 · Medivators · Jul 2014
US ENDOSCOPY DISTAL ATTACHMENT CAP
K140315 · United States Endoscopy Group, Inc. · Apr 2014