# K053008: E-Z-EM Endoscopic CO2 Regulator

- Pathway: 510(k) (Abbreviated)
- Applicant: E-Z-Em, Inc.
- Decided: Dec 27, 2005 after 62 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; 6 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
- K111648: Bracco Diagnostics, Inc. CO2MPACT Endodcopic Insufflator (2011), 3 descendants of its own
- K063786: Endoscopic Insufflation Unit, Model Xecr-2 (2007), 2 descendants of its own
- K133976: Fujifilm Endoscopic CO2 Regulator (2014), 1 descendant of its own
- K202922: END 200 Endoscopic Tubeset (2021), 0 descendants of its own
- K201096: CO2mbiLED (2020), 0 descendants of its own

## Indications for use
The E-Z-EM ENDOSCOPIC C02 REGULATOR is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. The ENDOSCOPIC C02 REGULATOR allows the physician to modulate and control the C02 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the Light Source of the Endoscopic equipment.

Source page: https://510kreport.com/device/K053008
Methodology: https://510kreport.com/methodology