# K991906: Laparo CO2-Pneu Automatic Insufflator with 30L Flow Rate,and Video-Screen Display, High Flow Insufflation Tube with Heat

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Nov 23, 1999 after 186 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 K955073 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955073: Ksea Thermoflator (Model 26 4320 20), KARL STORZ Endoscopy-America, Inc. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K081333: Laparo CO₂-Pneu 2232 (20 L). Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Indications for use
The Laparo CO₂-Pneu automatic insufflator generates and maintains pneumoperitoneum under CO₂ gas and can be used in diagnostic and operative laparoscopy.

Source page: https://510kreport.com/device/K991906
Methodology: https://510kreport.com/methodology