# K974155: BMR 4500 Filtered Venous Reservoir and BMR -4500 Gold Filtered Venous Reservoir with Duraflo Treatment

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jan 22, 1998 after 79 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.
29 later devices descend from it; 1 cites it directly.
2 of 30 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) Bentley HSR™-4000 Venous Reservoir with Cardiotomy Autotransfusion Filter: named in the summary without a submission number

## Most influential descendants
- K982223: Capiox SX Hardshell Resevoir (1998), 28 descendants of its own
- K991973: Capiox SX10 Hardshell Resevoir (1999), 27 descendants of its own
- K030449: Modification to Capiox SX10 Hardshell Reservoir (2003), 26 descendants of its own
- K051997: Capiox RX15 Hollow, Fiber Oxygenator with/Without Hardshell Reservoir (2005), 25 descendants of its own
- K090689: Quadrox-I Small Adult with and Without Intergrated Arterial Filter with Softline Coating, Models Hmo 50000, Hmo 51000 (2009), 9 descendants of its own

## Indications for use
The BMR™-4500 Filtered Venous Reservoir is indicated for use during cardiopulmonary bypass surgery in the extracorporeal circuit to collect, store, filter and defoam the patient’s blood. The BMR™-4500 GOLD® Hard Shell Venous Reservoir with Duraflo® treatment is indicated for use during cardiopulmonary bypass surgery in the extracorporeal circuit to collect, store, filter and defoam the patient’s blood. The BMR-4500 GOLD® is further intended for use when a heparin treated blood path is desired.

Source page: https://510kreport.com/device/K974155
Methodology: https://510kreport.com/methodology