# K222901: EVA15 insufflator

- Pathway: 510(k) (Traditional)
- Applicant: Palliare, Ltd.
- Decided: Jan 27, 2023 after 126 days
- Product code: HIF (Insufflator, Laparoscopic)
- Device class: 2
- Regulation: 21 CFR 884.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K964171 (1997). 33 ancestors in all.
3 later devices descend from it; 2 cite it directly.
3 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202799: EVA15, Palliare, Ltd. (2020) Summary page 4.

## Most influential descendants
- K230474: EVA5 Insufflator (2023), 1 descendant of its own
- K262152: VS-370CF, VS-370CT (2026), 0 descendants of its own
- K232902: EVA15 insufflator (2024), 0 descendants of its own

## Indications for use
The EVA15 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity with up to 25 mmHg pressure, by filling it with gas and to evacuate surgical smoke.

Source page: https://510kreport.com/device/K222901
Methodology: https://510kreport.com/methodology