# K063786: Endoscopic Insufflation Unit, Model Xecr-2

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Mar 5, 2007 after 74 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: 1 generation back to K881004 (1988). 2 ancestors in all.
2 later devices descend 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)
- K881004: Olympus-Keymed Endoscopic CO2 Regulator, Model Ecr, Keymed, Inc. (1988) Summary page 2.
- K053008: E-Z-EM Endoscopic CO2 Regulator, E-Z-Em, Inc. (2005) Summary page 2.

## Most influential descendants
- K133976: Fujifilm Endoscopic CO2 Regulator (2014), 1 descendant of its own
- K180711: FUJIFILM Endoscopic CO2 Regulator GW-100 (2018), 0 descendants of its own

## Indications for use
This instrument has been designed to be used with Olympus gastrointestinal endoscopes and other ancillary equipment for CO 2 gas and water feeding.

Source page: https://510kreport.com/device/K063786
Methodology: https://510kreport.com/methodology