# K140197: Pleur-Evac Plus Continuous Reinfusion and Autotransfusion System

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Oct 21, 2014 after 267 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 K911656 (1991). 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)
- K911656: Pleur-Evac Plus Contin. Reinfus. & Autoinfus. Syst, Pfizer Hospital Products Group, Inc. (1991) Summary page 5.

## Indications for use
For the collection of autologous blood from the patient’s pleural cavity or mediastinal area for reinfusion purposes in trauma and post-operative situations, To evacuate air and/or fluid from the chest cavity or mediastinum, To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum, To help re-establish and maintain normal intra-thoracic pressure gradients, To facilitate complete lung re-expansion to restore normal breathing dynamics.

Source page: https://510kreport.com/device/K140197
Methodology: https://510kreport.com/methodology