Cleared Traditional

K192258 - Disposable Valve Sets

K192258 is the FDA 510(k) clearance for Disposable Valve Sets by Zhejiang Chuangxiang Medical Technology Co., Ltd.. It is a Class 2 Gastroenterology & Urology device (product code ODC) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K192258 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Gastroenterology & Urology device
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Dec 2019
Decision
132d
Days
Class 2
Risk

K192258 is an FDA 510(k) clearance for the Disposable Valve Sets. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Zhejiang Chuangxiang Medical Technology Co., Ltd. (Hanzhou, CN). The FDA issued a Cleared decision on December 30, 2019 after a review of 132 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 Zhejiang Chuangxiang Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K192258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2019
Decision Date December 30, 2019
Days to Decision 132 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
2d slower than avg
Panel avg: 130d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - ODC Endoscope Channel Accessory

All 49
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K192258.
Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve
K200495 · Ga Health Company Limited · Jun 2020
Andorate Biopsy Valve, Andorate Biopsy Irrigator
K200481 · Ga Health Company Limited · Jun 2020
Single Use Endoscope Valves Set
K192048 · Anrei Medical (Hangzhou) Co., Ltd. · May 2020
Bio Guard Air/Water & Suction Valves
K192059 · United States Endoscopy Group, Inc. · Sep 2019
Andorate Auxiliary Water Connector, Andorate Valves Set
K191231 · Smartdata Suzhou Co., Ltd. · Jun 2019
CleverLock Guidewire Locking Device and Biopsy Cap
K190164 · Olympus Surgical Technologies America · Apr 2019