# K222812: Insufflator

- Pathway: 510(k) (Traditional)
- Applicant: Scivita Medical Technology Co., Ltd.
- Decided: May 16, 2023 after 239 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: 2 generations back to K001533 (2000). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030837: 40 L High Flow Insufflator F108, W.O.M. World of Medicine AG (2004) Summary page 6.

## Most influential descendants
- K252584: Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C) (2026), 0 descendants of its own
- K252318: Insufflator (OPTO-IFL1000) (2026), 0 descendants of its own

## Indications for use
The Insufflator is a device intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

Source page: https://510kreport.com/device/K222812
Methodology: https://510kreport.com/methodology