# K030837: 40 L High Flow Insufflator F108

- Pathway: 510(k) (Traditional)
- Applicant: W.O.M. World of Medicine AG
- Decided: Feb 5, 2004 after 325 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: 1 generation back to K001533 (2000). 1 ancestor in all.
51 later devices descend from it; 4 cite it directly.
2 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001533: Surgiflator-40, W.O.M. Gmhb (2000) Summary page 2.

## Most influential descendants
- K060723: 40 L High Flow Insufflator F113 (2006), 45 descendants of its own
- K063367: 45L Core Insufflator, Model F114 (2007), 44 descendants of its own
- K103692: Sugiquest Airsealoptical Trocar & Cannula System with Integrated Insufflator Dpis 2000 (2011), 35 descendants of its own
- K110294: High Flow Insufflation Unit Uhi-4 (2011), 32 descendants of its own
- K122180: High Flow Insufflantion Unit (2012), 31 descendants of its own

## Indications for use
The 40L High Flow Insufflator F108 with low flow mode is a device intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it. The low flow application of this device is indicated for pediatric use.

Source page: https://510kreport.com/device/K030837
Methodology: https://510kreport.com/methodology