# K223361: BMR 1900 Phisio

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Jun 10, 2023 after 219 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 5.

## Indications for use
The BMR1900 PHISIO Closed Venous Reservoir Bag is intended to be used in cardiopulmonary bypass procedures for periods of up to six hours.

Source page: https://510kreport.com/device/K223361
Methodology: https://510kreport.com/methodology