Cleared Traditional

BioGuard EUS Air/Water and Suction Valves (K202104) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202104 · STERIS Corporation · Gastroenterology & Urology device
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Jan 2021
Decision
169d
Days
Class 2
Risk

K202104 is an FDA 510(k) clearance for the BioGuard EUS Air/Water and Suction Valves. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on January 14, 2021 after a review of 169 days - an extended review 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: 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 STERIS Corporation devices

Submission Details

510(k) Number K202104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2020
Decision Date January 14, 2021
Days to Decision 169 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
39d slower than avg
Panel avg: 130d · This submission: 169d
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 47
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K202104.
JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve
K210625 · Fujifilm Medwork GmbH · Sep 2021
BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor
K210342 · STERIS Corporation · Sep 2021
AutoCap RX
K210353 · Boston Scientific Corporation · May 2021
BioGuard Air/Water and Suction Valves
K203630 · Steris Corporations · Jan 2021
Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B
K200769 · Wilson Instruments (Sha) Co., Ltd. · Jan 2021
Locking device
K202237 · Hangzhou AGS MedTech Co., Ltd. · Dec 2020