# K982712: Rapid Transfer Blood Bag Model a-1650, Rapid Transfer Blood Bag Model S-250

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Surgical Product (Genzyme Biosurgery)
- Decided: Dec 18, 1998 after 136 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Genzyme Surgical Products Pleur-evac Autotransfusion Blood Recovery Bag: named in the summary without a submission number
- (no number) Atrium Medical Corporation ATS Blood Bag: named in the summary without a submission number

## Indications for use
The Rapid Transfer Blood Bag is intended for use as a blood evacuation and reinfusion device for shed mediastinal and pleural drainage when used in conjunction with the Pleur-evac Continuous Reinfusion Autotransfusion Systems.

Source page: https://510kreport.com/device/K982712
Methodology: https://510kreport.com/methodology