# K191366: Vacutore Air/Water Bottle Tubing

- Pathway: 510(k) (Traditional)
- Applicant: Smartdata Suzhou Co., Ltd.
- Decided: Sep 6, 2019 after 107 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K091344: Endo SmartCap+. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K231602: Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing (2023), 0 descendants of its own

## Indications for use
The Vacutore® Air/Water Bottle Tubing (Model GAR025, GAR072 & GAR076) 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. It is a 24-hour multi-patient use device.

Source page: https://510kreport.com/device/K191366
Methodology: https://510kreport.com/methodology