# K964070: Deknatel DSP Pleur-Evac Autotransfusion Blood Recovery Bag

- Pathway: 510(k) (Traditional)
- Applicant: Deknatel, Inc.
- Decided: Dec 31, 1996 after 82 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
Longest line of descent: 1 generation back to K883663 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K883663: Ats Blood Recovery Bag, Atrium Medical Corp. (1988) Summary page 2.

## Indications for use
The Pleur-evac® Autotransfusion Blood Recovery Bag is a blood evacuation and collection device for shed mediastinal or pleural drainage, and is intended to be used in conjunction with DSP Pleur-evac® Continuous Reinfusion Autotransfusion Systems.

Source page: https://510kreport.com/device/K964070
Methodology: https://510kreport.com/methodology