# K200388: Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector

- Pathway: 510(k) (Traditional)
- Applicant: Ga Health Company Limited
- Decided: Apr 14, 2020 after 56 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: 6 generations back to K944759 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 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.
- K172916: FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603, Fujifilm Corporation (2018) Summary page 4.

## Indications for use
The Vacutore 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 Vacutore CO2 Source Tubing with Luer Connector 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/K200388
Methodology: https://510kreport.com/methodology