# K161733: Inspire SVR 1200, Inspire 6F C, Inspire 8F C

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Mar 8, 2017 after 258 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: 3 generations back to K980786 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112771: BMR1900 PH.I.S.I.O Venous Reservoir Bag, Sorin Group Italia S.R.L. (2011) Summary page 4.

## Indications for use
INSPIRE SVR 1200 with Ph.I.S.I.O. coating is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects and handles venous blood and suction blood from cardiotomy reservoir. The INSPIRE SVR 1200 is intended to be used for 6 hours or less.

Source page: https://510kreport.com/device/K161733
Methodology: https://510kreport.com/methodology