# K230474: EVA5 Insufflator

- Pathway: 510(k) (Special)
- Applicant: Palliare, Ltd.
- Decided: Mar 24, 2023 after 30 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: 12 generations back to K964171 (1997). 34 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193520: EVA 15 Insufflator, Palliare, Ltd. (2020) Summary page 4.
- K222901: EVA15 insufflator, Palliare, Ltd. (2023) Summary page 4.

## Most influential descendants
- K262152: VS-370CF, VS-370CT (2026), 0 descendants of its own

## Indications for use
The EVA5 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas.

Source page: https://510kreport.com/device/K230474
Methodology: https://510kreport.com/methodology