# K173545: TEMED Gas Diffuser

- Pathway: 510(k) (Traditional)
- Applicant: Temed
- Decided: Feb 14, 2018 after 90 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 K030469 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112975: Carbonaid C02 Diffuser, Cardia Innovation AB (2012) Summary page 7.

## Indications for use
The TEMED 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 which can result in organ damage.

Source page: https://510kreport.com/device/K173545
Methodology: https://510kreport.com/methodology