# K112357: Vessel Guardian

- Pathway: 510(k) (Traditional)
- Applicant: Lexion Medical, LLC
- Decided: Nov 10, 2011 after 86 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: 6 generations back to K920986 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102136: Vessel Guardian, Lexion Medical, LLC (2010) Summary page 1.
- K090456: Insuflow, Lexion Medical, LLC (2009) Summary page 1.

## Indications for use
Vessel VaporTM is a gas conditioner accessory device intended to heat, humidify and filter an insufflating CO2 gas stream being used in minimally invasive cardiovascular, thoracoscopic, and vessel harvesting surgical procedures.

Source page: https://510kreport.com/device/K112357
Methodology: https://510kreport.com/methodology