# K162332: Nexcore GI Insufflator

- Pathway: 510(k) (Traditional)
- Applicant: Nexcore Technology, LLC
- Decided: Sep 29, 2016 after 41 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: 5 generations back to K923982 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111648: Bracco Diagnostics, Inc. CO2MPACT Endodcopic Insufflator, Bracco Diagnostic, Inc. (2011) Summary page 4.

## Indications for use
The Nexcore GI Insufflator is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. The Nexcore GI 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/K162332
Methodology: https://510kreport.com/methodology