# K240847: MedicCO2LON (MedicCO2LON)

- Pathway: 510(k) (Traditional)
- Applicant: Ide Vision, Ltd.
- Decided: Oct 30, 2024 after 217 days
- Product code: FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope)
- 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: 3 generations back to K013219 (2002). 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)
- K132192: Bracco Diagnostics Inc. Protoco, L Touch Colon Insufflator, Bracco Diagnostic, Inc. (2014) Summary page 5.

## Indications for use
The MedicCO2LON device is intended to be used for colonic distension with CO2 gas for CT Colonography and conventional Colonoscopy procedures. MedicCO2LON is designed to function with specific colonic insufflation administration sets that allow passage of gas from the device to the colorectal cavity. MedicCO2LON should only be used with administration sets specifically designed for this purpose. The device should only be used by personnel trained in the practice of undertaking CT Colonography and conventional Colonoscopy examinations and the use of an automatic insuffiation device. The device should only be used for CT Colonography or conventional Colonoscopy procedures and should not be used for any other patient examination procedure.

Source page: https://510kreport.com/device/K240847
Methodology: https://510kreport.com/methodology