Cleared Traditional

troCarWash™ System (K222695) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222695 · Biotex, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
164d
Days
Class 2
Risk

K222695 is an FDA 510(k) clearance for the troCarWash™ System. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Biotex, Inc. (Houston, US). The FDA issued a Cleared decision on February 17, 2023 after a review of 164 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Biotex, Inc. devices

Submission Details

510(k) Number K222695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2022
Decision Date February 17, 2023
Days to Decision 164 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 115d · This submission: 164d
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 General & Plastic Surgery 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 K222695.
Protego Air Water Connector
K231602 · Ga Health Company Limited · Aug 2023
ANDORATE® Valve Kit
K230932 · Ga Health Company Limited · Jul 2023
Saneso Lens Wash Bottle Assembly (SAN-LWB-A)
K222173 · Saneso, Inc. · Feb 2023
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