Cleared Traditional

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing (K222734) - FDA 510(k) Clearance

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

K222734 · Diversatek Healthcare · Gastroenterology & Urology device
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Nov 2022
Decision
60d
Days
Class 2
Risk

K222734 is an FDA 510(k) clearance for the Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Diversatek Healthcare (Milwaukee, US). The FDA issued a Cleared decision on November 8, 2022 after a review of 60 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 Diversatek Healthcare devices

Submission Details

510(k) Number K222734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2022
Decision Date November 08, 2022
Days to Decision 60 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
70d faster than avg
Panel avg: 130d · This submission: 60d
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 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 K222734.
Saneso Lens Wash Bottle Assembly (SAN-LWB-A)
K222173 · Saneso, Inc. · Feb 2023
troCarWash™ System
K222695 · Biotex, Inc. · Feb 2023
AquaPulse® Irrigation Tubing
K223171 · Ga Health Company Limited · Nov 2022
Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing
K221310 · Changzhou Endoclean Medical Device Co., Ltd. · Oct 2022
Clean Connecting Tube
K220785 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Sep 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