# K111648: Bracco Diagnostics, Inc. CO2MPACT Endodcopic Insufflator

- Pathway: 510(k) (Special)
- Applicant: Bracco Diagnostic, Inc.
- Decided: Nov 3, 2011 after 143 days
- Product code: FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K923982 (1993). 9 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053008: E-Z-EM Endoscopic CO2 Regulator, E-Z-Em, Inc. (2005) Summary page 1.
- K081173: Endoscopic CO2 Regulation Unit Ucr, Olympus Medical Systems Corporation (2008) Summary page 1.

## Most influential descendants
- K201096: CO2mbiLED (2020), 0 descendants of its own
- K190985: BAROnova Insufflation System, BAROnova Accessory Kit (2019), 0 descendants of its own
- K162332: Nexcore GI Insufflator (2016), 0 descendants of its own

## Recalls of this device
- Jan 15, 2021 · Class II · Z-1148-2021: An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.

## Indications for use
The Bracco Diagnostics, Inc. (BDI) CO2 MPACT ENDOSCOPIC INSUFFLATOR is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. The BDI CO2 MPACT ENDOSCOPIC INSUFFLATOR allows the physician to modulate and control the CO2 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/K111648
Methodology: https://510kreport.com/methodology