Cleared Traditional

K200388 - Vacutore Air/Water Bottle Tubing

K200388 is an FDA 510(k) clearance for Vacutore Air/Water Bottle Tubing, manufactured by Ga Health Company Limited. The device is a Class 2 Gastroenterology & Urology device with product code OCX cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K200388 · Ga Health Company Limited · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
56d
Days
Class 2
Risk

K200388 is an FDA 510(k) clearance for the Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Ga Health Company Limited (Hong Kong, CN). The FDA issued a Cleared decision on April 14, 2020 after a review of 56 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 Ga Health Company Limited devices

FDA 510(k) Submission Details - K200388

510(k) Number K200388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2020
Decision Date April 14, 2020
Days to Decision 56 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
74d faster than avg
Panel avg: 130d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

OCX Device Classification - Class 2, Special Controls

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

Accelerated Device Approval Services
Rafael Aguila

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 66
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K200388.
ClearCap Distal Attachment
K202616 · Finemedix Co., Ltd. · Feb 2021
AquaPulse Irrigation Tubing
K202560 · Ga Health Company Limited · Dec 2020
AquaPulse Auxiliary Water Connector
K200479 · Ga Health Company Limited · May 2020
Irrigation Tubing with CO2 or Air
K193250 · Keymed (Medical and Industrial Equipment) , Ltd. · Apr 2020
C2 CryoBalloon EndoGrip
K193036 · Pentax Medical, A Division of Pentax of America, Inc. · Nov 2019
Vacutore Air/Water Bottle Tubing
K191366 · Smartdata Suzhou Co., Ltd. · Sep 2019

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.