# K030854: PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400

- Pathway: 510(k) (Special)
- Applicant: E-Z-Em, Inc.
- Decided: Apr 16, 2003 after 29 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 K013219 (2002). 1 ancestor in all.
10 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013219: PROTOCO2L Insufflator Model 6400, E-Z-Em, Inc. (2002)

## Most influential descendants
- K100624: Invendo C20 Colonoscopy System (2012), 6 descendants of its own
- K121582: Invendo C25 Colonoscopy System (2012), 5 descendants of its own
- K141286: Aer-O-Scope Colonoscope System (2014), 2 descendants of its own
- K161355: invendoscopy E200 System (2016), 1 descendant of its own
- K132192: Bracco Diagnostics Inc. Protoco, L Touch Colon Insufflator (2014), 1 descendant of its own

## Indications for use
The E-Z-EM PROTOCO2L COLON Insufflator administers and regulates carbon dioxide (C02) as a distention media to the colon during CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy.

Source page: https://510kreport.com/device/K030854
Methodology: https://510kreport.com/methodology