# K190985: BAROnova Insufflation System, BAROnova Accessory Kit

- Pathway: 510(k) (Traditional)
- Applicant: Baronova, Inc.
- Decided: May 14, 2019 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: 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 5.

## Indications for use
The BAROnova Insufflation System is designed to use air as a distention media in the gastrointestinal tract when used in conjunction with the BAROnova TPS Delivery Device. The BAROnova Accessory Kit, consisting of the BAROnova Insufflation System, TPS Stand, and Hook Tool is designed to facilitate use of the BAROnova TPS Delivery Device.

Source page: https://510kreport.com/device/K190985
Methodology: https://510kreport.com/methodology