# K202799: EVA15

- Pathway: 510(k) (Special)
- Applicant: Palliare, Ltd.
- Decided: Oct 21, 2020 after 28 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: 10 generations back to K964171 (1997). 32 ancestors in all.
4 later devices descend from it; 1 cites 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)
- K193520: EVA 15 Insufflator, Palliare, Ltd. (2020) Summary page 4.

## Most influential descendants
- K222901: EVA15 insufflator (2023), 3 descendants of its own
- 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 EVA1S5 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 15 mmHg pressure, by filling it with gas and to evacuate surgical smoke.

Source page: https://510kreport.com/device/K202799
Methodology: https://510kreport.com/methodology