Cleared Traditional

K192258 - Disposable Valve Sets

K192258 is an FDA 510(k) clearance for Disposable Valve Sets, manufactured by Zhejiang Chuangxiang Medical Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with 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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K192258

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
1d slower than avg
Panel avg: 131d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODC Device Classification - Class 2, Special Controls

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 57
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