# K140205: Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion System

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Oct 23, 2014 after 269 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K801043 (1980). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130043: Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System, Teleflexmedical, Inc. (2013) Summary page 5.

## Most influential descendants
- K193361: ProCell Surgical Sponge-Blood Recovery Unit (2020), 0 descendants of its own

## Recalls of this device
- Mar 30, 2016 · Class II · Z-1582-2016: The label on the Tyvek bag is missing. This is used by customers to identify material code, lot number, and expiration date once the product is removed from the shipper box.

## 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/K140205
Methodology: https://510kreport.com/methodology