# K050111: Smarxt BMR 1900 Closed Venous Reservoir Bag

- Pathway: 510(k) (Abbreviated)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Mar 8, 2005 after 49 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: 1 generation back to K980786 (1998). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980786: Cobe Closed Venous Reservoir Bags with Smarx T, Models VRB 1200 and VRB 1800, Cobe Cardiovascular, Inc. (1998) Summary page 1.

## Most influential descendants
- K112771: BMR1900 PH.I.S.I.O Venous Reservoir Bag (2011), 2 descendants of its own
- K070605: Jostra Venous Softbag Reservoirs with and Without Safeline Coating (2008), 1 descendant of its own
- 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
- K090690: Venous Softbag Reservoirs with Softline Coating (2009), 0 descendants of its own

## Indications for use
The SMARxT® BMR1900TM Closed Venous Reservoir Bag 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/K050111
Methodology: https://510kreport.com/methodology