Cleared Traditional

K191231 - Andorate Auxiliary Water Connector

K191231 is the FDA 510(k) clearance for Andorate Auxiliary Water Connector by Smartdata Suzhou Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code ODC) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K191231 · Smartdata Suzhou Co., Ltd. · Gastroenterology & Urology device
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Jun 2019
Decision
30d
Days
Class 2
Risk

K191231 is an FDA 510(k) clearance for the Andorate Auxiliary Water Connector, Andorate Valves Set. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Smartdata Suzhou Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on June 7, 2019 after a review of 30 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smartdata Suzhou Co., Ltd. devices

Submission Details

510(k) Number K191231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2019
Decision Date June 07, 2019
Days to Decision 30 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
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code ODC Endoscope Channel Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Give The Endoscope Channel Additional Or Improved Functionality.
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 - ODC Endoscope Channel Accessory

All 49
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K191231.
Single Use Endoscope Valves Set
K192048 · Anrei Medical (Hangzhou) Co., Ltd. · May 2020
Disposable Valve Sets
K192258 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Dec 2019
Bio Guard Air/Water & Suction Valves
K192059 · United States Endoscopy Group, Inc. · Sep 2019
CleverLock Guidewire Locking Device and Biopsy Cap
K190164 · Olympus Surgical Technologies America · Apr 2019
San Antonio Stopcock
K181712 · Cook Incorporated · Jul 2018
Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter
K173105 · Cook Incorporated · Mar 2018

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.