# K091366: Insuflow Dewheart

- Pathway: 510(k) (Traditional)
- Applicant: Lexion Medical, LLC
- Decided: Sep 3, 2009 after 118 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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.
- K983135: Blower/Mister, Cardiothoracic Systems, Inc. (1998) Summary page 1.

## Indications for use
The Insuflow®DewHeart TM is a Blower/Mister Gas conditioner device for use in cardiovascular surgical procedures intended to heat, humidify and filter a CO 2 gas stream for introduction into the surgical cavity to improve visibility and reduce the risk of air embolism.

Source page: https://510kreport.com/device/K091366
Methodology: https://510kreport.com/methodology