# K090879: Insuflow CO2IONSHIELD

- Pathway: 510(k) (Traditional)
- Applicant: Lexion Medical, LLC
- Decided: Jul 23, 2009 after 114 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 K920986 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063546: Insuflow Device, Model 6198, Lexion Medical, LLC (2007) Summary page 1.
- K030854: PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400, E-Z-Em, Inc. (2003) Summary page 1.
- K053008: E-Z-EM Endoscopic CO2 Regulator, E-Z-Em, Inc. (2005) Summary page 1.

## Indications for use
Insuflow®CO 2 lonShieldTM is a gas conditioner accessory device for use during colonoscopy procedures, including CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy procedures, and intraoperative endoscopy procedures, intended to heat, humidify and filter a CO 2 gas stream for administration as a distention media.

Source page: https://510kreport.com/device/K090879
Methodology: https://510kreport.com/methodology