# K013219: PROTOCO2L Insufflator Model 6400

- Pathway: 510(k) (Abbreviated)
- Applicant: E-Z-Em, Inc.
- Decided: Feb 19, 2002 after 146 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
No predicates in its family tree.
11 later devices descend from it; 2 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K030854: PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400 (2003), 10 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K013219
Methodology: https://510kreport.com/methodology