# K130433: Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow Fiber Oxygenator with Integrate

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Mar 20, 2013 after 27 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K922933 (1992). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122254: Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir, Sorin Group Italia S.R.L. (2012) Summary page 1.
- 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
- 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

## Recalls of this device
- Mar 13, 2018 · Class II · Z-1919-2018: Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically

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

Source page: https://510kreport.com/device/K130433
Methodology: https://510kreport.com/methodology