# K112771: BMR1900 PH.I.S.I.O Venous Reservoir Bag

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Oct 14, 2011 after 21 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: 2 generations back to K980786 (1998). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050111: Smarxt BMR 1900 Closed Venous Reservoir Bag, Cobe Cardiovascular, Inc. (2005) Summary page 1.

## Most influential descendants
- K223361: BMR 1900 Phisio (2023), 0 descendants of its own
- K161733: Inspire SVR 1200, Inspire 6F C, Inspire 8F C (2017), 0 descendants of its own

## Indications for use
The BMR1900 PH.I.S.I.O. is intended to be used in cardiac surgical procedures requiring extracorporeal support for periods of up to six hours.

Source page: https://510kreport.com/device/K112771
Methodology: https://510kreport.com/methodology