# K130209: Inspire 6 Hollow Fiber Oxygenator with Integrated Hardhell Reservoir, Inspire 6F Hollow Fiber Oxygenator with Integrated

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Feb 12, 2013 after 14 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). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113626: Inspire 6 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir, Sorin Group Italia S.R.L. (2012) Summary page 1.
- K120185: Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservior, Sorin Group Italia S.R.L. (2012) Summary page 1.

## Recalls of this device
- Mar 13, 2018 · Class II · Z-1918-2018: 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 6M: Hollow Fiber Oxygenator INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 6M 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 6F M: Hollow Fiber Oxygenator The INSPIRE 6F 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 6F M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 6F M 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.

Source page: https://510kreport.com/device/K130209
Methodology: https://510kreport.com/methodology