# K090456: Insuflow

- Pathway: 510(k) (Traditional)
- Applicant: Lexion Medical, LLC
- Decided: Aug 26, 2009 after 184 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: 3 generations back to K920986 (1992). 8 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063546: Insuflow Device, Model 6198, Lexion Medical, LLC (2007) Summary page 1.
- K052125: Carbonaid Gas Diffuser, Cardia Innovation AB (2006) Summary page 1.

## Most influential descendants
- 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
- K170799: AP 50/30 Insufflator with Insuflow Port (2017), 1 descendant of its own

## Indications for use
Insuflow® is a gas conditioner accessory device for use in minimally invasive surgery, including thoracoscopic, laparoscopic and endoscopic vein harvesting surgical procedures, intended to heat, humidify and filter a CO 2 gas stream for insufflation of the surgical cavity.

Source page: https://510kreport.com/device/K090456
Methodology: https://510kreport.com/methodology