# K980786: Cobe Closed Venous Reservoir Bags with Smarx T, Models VRB 1200 and VRB 1800

- Pathway: 510(k) (Traditional)
- Applicant: Cobe Cardiovascular, Inc.
- Decided: Aug 24, 1998 after 175 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
No predicates in its family tree.
6 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) COBE® VRB® 1200™ Closed Venous Reservoir Bag: named in the summary without a submission number

## Most influential descendants
- K050111: Smarxt BMR 1900 Closed Venous Reservoir Bag (2005), 5 descendants of its own
- 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

## Indications for use
The COBE® Closed Venous Reservoir Bags With SMAR, T™ (Model Numbers VRB® 1200™ and VRB® 1800™) are intended to be used in adult surgical procedures requiring extracorporeal support for periods of up to six hours.

Source page: https://510kreport.com/device/K980786
Methodology: https://510kreport.com/methodology