# K231471: Air/Water Bottle Tubing, CO2 Source Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.
- Decided: Sep 8, 2023 after 109 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: 2 generations back to K790071 (1979). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093665: Endo Smartcap, Byrne Medical, Inc. (2009) Summary page 4.

## Indications for use
The Air/Water Bottle Tubing is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. The CO2 Source Tubing is intended to be used with a carbon dioxide (CO2) source with the purpose of supplying CO2 to the endoscope during endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device.

Source page: https://510kreport.com/device/K231471
Methodology: https://510kreport.com/methodology