# K123047: Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Bracco Diagnostic, Inc.
- Decided: Aug 6, 2013 after 312 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 K853585 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053008: E-Z-EM Endoscopic CO2 Regulator, E-Z-Em, Inc. (2005) Summary page 1.
- K954451: Evis 140 System, Olympus America, Inc. (1996) Summary page 1.

## Indications for use
The CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET is intended to connect a CO2 source (insuflator), and a sterile water source (water bottle), to an endoscope to supply CO2 during gastrointestinal endoscopic procedures.

Source page: https://510kreport.com/device/K123047
Methodology: https://510kreport.com/methodology