# K132192: Bracco Diagnostics Inc. Protoco, L Touch Colon Insufflator

- Pathway: 510(k) (Traditional)
- Applicant: Bracco Diagnostic, Inc.
- Decided: Feb 14, 2014 after 214 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: 2 generations back to K013219 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030854: PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400, E-Z-Em, Inc. (2003) Summary page 1.
- K013219: PROTOCO2L Insufflator Model 6400, E-Z-Em, Inc. (2002) Summary page 1.

## Most influential descendants
- K240847: MedicCO2LON (MedicCO2LON) (2024), 0 descendants of its own

## Indications for use
The PROTOCO₂ L Touch Colon Insufflator administers and regulates CO₂ as a distention media to the colon during Computed Tomography Colonography (CTC or Virtual Colonoscopy).

Source page: https://510kreport.com/device/K132192
Methodology: https://510kreport.com/methodology