# K122844: Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Reservoir

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Oct 17, 2012 after 30 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: 5 generations back to K922933 (1992). 8 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121536: Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell Reservoir, Sorin Group Italia S.R.L. (2012) Summary page 1.

## Most influential descendants
- K251783: Inspire HCR and HCR DUAL cardiotomy reservoirs (2025), 0 descendants of its own
- K241206: Quantum Perfusion Hybrid System (2024), 0 descendants of its own
- 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 (2020), 0 descendants of its own

## Indications for use
INSPIRE 8F M: Hollow Fiber Oxygienator INSPIRE 8F M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 8F M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 8F M is intended to be used for 6 hours or less. INSPIRE HVR DUAL: Hardshell Venous/Cardiotomy Reservoir INSPIRE HVR DUAL is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, defoams and filters venous blood and suction blood. INSPIRE HVR DUAL can be used post-operatively for chest drainage. INSPIRE HVR DUAL is intended to be used for 6 hours or less.

Source page: https://510kreport.com/device/K122844
Methodology: https://510kreport.com/methodology