# K112975: Carbonaid C02 Diffuser

- Pathway: 510(k) (Traditional)
- Applicant: Cardia Innovation AB
- Decided: Jun 22, 2012 after 261 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 K030469 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052125: Carbonaid Gas Diffuser, Cardia Innovation AB (2006) Summary page 2.

## Most influential descendants
- K173545: TEMED Gas Diffuser (2018), 0 descendants of its own

## Indications for use
The CarbonAid® CO 2 diffuser is intended for use by cardiovascular surgeons in open heart surgery procedures for the insufflation of carbon dioxide gas into the thoracic cavity to reduce the risk of air embolism which can result in organ damage.

Source page: https://510kreport.com/device/K112975
Methodology: https://510kreport.com/methodology