# K220785: Clean Connecting Tube

- Pathway: 510(k) (Traditional)
- Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd.
- Decided: Sep 27, 2022 after 194 days
- Product code: OCX (Endoscopic Irrigation/Suction System)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K884836 (1988). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102855: Universal Irrigation Solution Hybrid, Byrne Medical, Inc. (2010) Summary page 4.

## Indications for use
The Clean Connecting Tube (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air(via an air pump) or C02(Via a C02 pump) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.

Source page: https://510kreport.com/device/K220785
Methodology: https://510kreport.com/methodology