# K133976: Fujifilm Endoscopic CO2 Regulator

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Sep 9, 2014 after 257 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 K881004 (1988). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063786: Endoscopic Insufflation Unit, Model Xecr-2, Olympus Medical Systems Corporation (2007) Summary page 5.

## Most influential descendants
- K180711: FUJIFILM Endoscopic CO2 Regulator GW-100 (2018), 0 descendants of its own

## Indications for use
This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm’s endoscopy system.

Source page: https://510kreport.com/device/K133976
Methodology: https://510kreport.com/methodology