# K063546: Insuflow Device, Model 6198

- Pathway: 510(k) (Special)
- Applicant: Lexion Medical, LLC
- Decided: Jan 10, 2007 after 47 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 K920986 (1992). 5 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970866: Filter Heater/Hydrator Insufflation Gas Conditioner, Georgia Biomedical, Inc. (1998) Summary page 2.

## Most influential descendants
- K090456: Insuflow (2009), 9 descendants of its own
- K120640: Insuflow Synergy Port (2012), 5 descendants of its own
- K132204: Insuflow Synergy XL Port (2013), 3 descendants of its own
- K140263: Insuflow Synergy Port, Insuflow Synergy XL Port (2014), 2 descendants of its own
- K101320: Vasovapor (2010), 2 descendants of its own

## Indications for use
The Lexion Medical Insuflow®device is an accessory to an insufflator intended to heat, humidify and filter a gas stream used for inflation during laparoscopic surgery.

Source page: https://510kreport.com/device/K063546
Methodology: https://510kreport.com/methodology