# K090652: Alpha Duo Lap Insufflator

- Pathway: 510(k) (Traditional)
- Applicant: Hippokratec GmbH
- Decided: Sep 25, 2009 after 198 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011510: Multi HI-Flo Pneu, Wisap #7080, Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh (2002) Summary page 2.
- K030837: 40 L High Flow Insufflator F108, W.O.M. World of Medicine AG (2004) Summary page 2.
- K070783: Sopro Model 640 Laparoscopic Insufflator, Sopro (2007) Summary page 2.

## Indications for use
The intended use of the Laparoscopic Insufflator ALPHA DUO LAP is to establish and maintain a pneumoperitoneum with C02 gas for diagnostic or operative Laparoscopy.

Source page: https://510kreport.com/device/K090652
Methodology: https://510kreport.com/methodology