# 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

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Mar 15, 2018 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: 6 generations back to K922933 (1992). 17 ancestors in all.
5 later devices descend from it; 5 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120185: Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservior, Sorin Group Italia S.R.L. (2012) Summary page 7.
- K113626: Inspire 6 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir, Sorin Group Italia S.R.L. (2012) Summary page 9.
- K121536: Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell Reservoir, Sorin Group Italia S.R.L. (2012) Summary page 11.
- K121229: Inspire 8 Dual Hollow Fiber Oxygenator with with Integrated Hardshell Venous/Cardiotomy, Sorin Group Italia S.R.L. (2012) Summary page 13.

## Most influential descendants
- K261438: HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (2026), 0 descendants of its own
- K250821: Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) (2025), 0 descendants of its own
- K212341: Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U (2022), 0 descendants of its own
- K201916: Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator (2020), 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 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 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 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. The INSPIRE 8M 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.

Source page: https://510kreport.com/device/K180448
Methodology: https://510kreport.com/methodology