Cleared Traditional

Endorate Valve Sets (K181509) - FDA 510(k) Clearance

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

K181509 · Smartdata Suzhou Co., Ltd. · Gastroenterology & Urology device
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Jul 2018
Decision
28d
Days
Class 2
Risk

K181509 is an FDA 510(k) clearance for the Endorate Valve Sets. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Smartdata Suzhou Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on July 6, 2018 after a review of 28 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 K181509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2018
Decision Date July 06, 2018
Days to Decision 28 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
102d faster than avg
Panel avg: 130d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code OCX Endoscopic Irrigation/suction System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.
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

Third Party Review Group, LLC
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Regulatory Peers - OCX Endoscopic Irrigation/suction System

All 92
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K181509.
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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.