# K200683: INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Jun 12, 2020 after 88 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). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130433: Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow Fiber Oxygenator with Integrate, Sorin Group Italia S.R.L. (2013) Summary page 10.
- 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 10.
- K122844: Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Reservoir, Sorin Group Italia S.R.L. (2012) Summary page 10.

## Indications for use
The Inspire 7F M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F M is intended to be used for 6 hours or less. The Inspire 7F is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F is intended to be used for 6 hours or less. The Inspire 7F Dual is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The integrated arterial filter provides additional protection against air and solid emboli. The Inspire 7F Dual is intended to be used for 6 hours or less.

Source page: https://510kreport.com/device/K200683
Methodology: https://510kreport.com/methodology