# K251783: Inspire HCR and HCR DUAL cardiotomy reservoirs

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Dec 22, 2025 after 194 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K922933 (1992). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130433: Inspire 8 Hollow Fiber Oxygenator with Integrated Hardshell Reservoir, Inspire 8F Hollow Fiber Oxygenator with Integrate, Sorin Group Italia S.R.L. (2013) Summary page 6.
- K122844: Inspire 8F Dual Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell Reservoir, Sorin Group Italia S.R.L. (2012) Summary page 6.

## Indications for use
The Inspire HCR and Inspire HCR DUAL cardiotomy reservoir are a device allowing suction blood recovery during extracorporeal circulation procedures, by providing blood collection and storage. In addition, the device supports extracorporeal system priming and defoams and filters suctioned blood. The Inspire HCR must be used up to 6 hours or less.

Source page: https://510kreport.com/device/K251783
Methodology: https://510kreport.com/methodology