# K102136: Vessel Guardian

- Pathway: 510(k) (Traditional)
- Applicant: Lexion Medical, LLC
- Decided: Sep 27, 2010 after 60 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: 5 generations back to K920986 (1992). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101320: Vasovapor, Lexion Medical, LLC (2010) Summary page 1.
- K090456: Insuflow, Lexion Medical, LLC (2009) Summary page 1.

## Most influential descendants
- K112357: Vessel Guardian (2011), 0 descendants of its own

## Indications for use
Vessel Guardian ®is a gas conditioner accessory device for use in endoscopic vessel harvesting surgical procedures, intended to heat, humidify and filter a CO 2 gas stream for insuflation of the surgical cavity.

Source page: https://510kreport.com/device/K102136
Methodology: https://510kreport.com/methodology