Cleared Traditional

Clean Connecting Tube (K220785) - FDA 510(k) Clearance

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

K220785 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
194d
Days
Class 2
Risk

K220785 is an FDA 510(k) clearance for the Clean Connecting Tube. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Yangzhou Fartley Medical Instrument Technology Co., Ltd. (Yangzhou, CN). The FDA issued a Cleared decision on September 27, 2022 after a review of 194 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 Yangzhou Fartley Medical Instrument Technology Co., Ltd. devices

Submission Details

510(k) Number K220785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2022
Decision Date September 27, 2022
Days to Decision 194 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
64d slower than avg
Panel avg: 130d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Shanghai Thinkwell Consulting Co., Ltd.
Ethan Liu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OCX Endoscopic Irrigation/suction System

All 46
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K220785.
AquaPulse® Irrigation Tubing
K223171 · Ga Health Company Limited · Nov 2022
Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
K222734 · Diversatek Healthcare · Nov 2022
Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing
K221310 · Changzhou Endoclean Medical Device Co., Ltd. · Oct 2022
OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315
K221824 · Cipher Surgical Limited · Aug 2022
Erbe's Tubing/Cap Sets
K221177 · Erbe USA, Inc. · Aug 2022
Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series
K210618 · Chongqing Jinshan Science & Technology Co., Ltd. · Oct 2021