# K052125: Carbonaid Gas Diffuser

- Pathway: 510(k) (Traditional)
- Applicant: Cardia Innovation AB
- Decided: Feb 8, 2006 after 187 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: 1 generation back to K030469 (2003). 1 ancestor in all.
13 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030469: Laparoshield Conditioned Insufflation Set, Pall Medical (2003) Summary page 1.

## Most influential descendants
- K090456: Insuflow (2009), 9 descendants of its own
- 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

## Indications for use
The CarbonAidTM gas 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.

Source page: https://510kreport.com/device/K052125
Methodology: https://510kreport.com/methodology