Cleared Traditional

K221331 - Disposable Endoscope Valves System

K221331 is an FDA 510(k) clearance for Disposable Endoscope Valves System, manufactured by Changzhou Endoclean Medical Device Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code ODC cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K221331 · Changzhou Endoclean Medical Device Co., Ltd. · Gastroenterology & Urology device
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Sep 2022
Decision
126d
Days
Class 2
Risk

K221331 is an FDA 510(k) clearance for the Disposable Endoscope Valves System. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Changzhou Endoclean Medical Device Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on September 8, 2022 after a review of 126 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 Changzhou Endoclean Medical Device Co., Ltd. devices

FDA 510(k) Submission Details - K221331

510(k) Number K221331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2022
Decision Date September 08, 2022
Days to Decision 126 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
4d faster than avg
Panel avg: 130d · This submission: 126d
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 50
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K221331.
ANDORATE® Valve Kit
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Pentax Medical Valve Set
K222980 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Nov 2022
Disposable Endoscopy Adapter Set
K220210 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Jun 2022
FROG Forceps Valve (VAL1-F1-100)
K221264 · Fujifilm Medwork GmbH · Jun 2022
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K213483 · Wilson Cook Medical · Apr 2022