Cleared Special

K191438 - ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector

K191438 is an FDA 510(k) clearance for ERBEFLO 2 Endo Quick Connect Pentax Sco..., manufactured by Erbe USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCX cleared through the Special 510(k) pathway after a 28-day FDA review.

K191438 · Erbe USA, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
28d
Days
Class 2
Risk

K191438 is an FDA 510(k) clearance for the ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Erbe USA, Inc. (Marietta, US). The FDA issued a Cleared decision on June 27, 2019 after a review of 28 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.

FDA 510(k) Submission Details - K191438

510(k) Number K191438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2019
Decision Date June 27, 2019
Days to Decision 28 days
Submission Type Special
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
103d faster than avg
Panel avg: 131d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K191438.
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K190469 · Erbe USA, Inc. · May 2019
Andorate Auxiliary Water Connector
K182998 · Smartdata Suzhou Co., Ltd. · Apr 2019
Glo-Tip Spray Catheter
K182319 · Wilson-Cook Medical, Inc. · Feb 2019
K191438 · ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector
Download PDF FDA Summary Erbe USA, Inc.