Cleared Traditional

K191366 - Vacutore Air/Water Bottle Tubing

K191366 is the FDA 510(k) clearance for Vacutore Air/Water Bottle Tubing by Smartdata Suzhou Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code OCX) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K191366 · Smartdata Suzhou Co., Ltd. · Gastroenterology & Urology device
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Sep 2019
Decision
107d
Days
Class 2
Risk

K191366 is an FDA 510(k) clearance for the Vacutore Air/Water Bottle Tubing. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Smartdata Suzhou Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on September 6, 2019 after a review of 107 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.

View all Smartdata Suzhou Co., Ltd. devices

Submission Details

510(k) Number K191366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2019
Decision Date September 06, 2019
Days to Decision 107 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 130d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Consultant

Accelerated Device Approval Services
Rafael Aguila

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OCX Endoscopic Irrigation/suction System

All 58
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K191366.
Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector
K200388 · Ga Health Company Limited · Apr 2020
Irrigation Tubing with CO2 or Air
K193250 · Keymed (Medical and Industrial Equipment) , Ltd. · Apr 2020
C2 CryoBalloon EndoGrip
K193036 · Pentax Medical, A Division of Pentax of America, Inc. · Nov 2019
ScopeFlow Pure(TM)
K181418 · Partnership Medical Limited · Jul 2019
EndoStream(TM)
K181457 · Partnership Medical Limited · Jul 2019
ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector
K191438 · Erbe USA, Inc. · Jun 2019

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.