# K261438: HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)

- Pathway: 510(k) (Traditional)
- Applicant: Eurosets S.R.L
- Decided: Sep 14, 2026 after 137 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K922933 (1992). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180448: INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter, Sorin Group Italia S.R.L. (2018) Summary page 5.
- K120185: Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservior, Sorin Group Italia S.R.L. (2012) Summary page 5.

## Indications for use
HORIZON 8AF is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. HORIZON 8AF integrated arterial filter provides additional protection against air and solid emboli. HORIZON 8AF includes Horizon CVR which collects, defoams and filters venous blood and suction blood. Horizon CVR can be used post-operatively for chest drainage. HORIZON 8AF is intended to be used for 6 hours or less.

Source page: https://510kreport.com/device/K261438
Methodology: https://510kreport.com/methodology