# K121536: Inspire 8F Oxygenator with Integrated Arterial Filter & Hardshell Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Aug 22, 2012 after 90 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: 4 generations back to K922933 (1992). 7 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033323: D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator with Coating, Dideco S.P.A. (2004) Summary page 1.
- K040184: Dideco Micro 40 PH.I.S.I.O. Adult Arterial Filter, Cobe Cardiovascular, Inc. (2004) Summary page 1.

## Most influential descendants
- 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 (2018), 5 descendants of its own
- K122844: Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Reservoir (2012), 3 descendants of its own
- K130433: Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow Fiber Oxygenator with Integrate (2013), 2 descendants of its own
- K261438: HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (2026), 0 descendants of its own
- K251783: Inspire HCR and HCR DUAL cardiotomy reservoirs (2025), 0 descendants of its own

## Indications for use
INSPIRE 8F M: Hollow Fiber Oxygenator The 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 SF 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: 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/K121536
Methodology: https://510kreport.com/methodology