# K031554: S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Biosurgery
- Decided: Jul 25, 2003 after 67 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: 2 generations back to K801043 (1980). 8 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963850: Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System, Deknatel, Inc. (1997) Summary page 2.

## Most influential descendants
- K120953: Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion System (2012), 3 descendants of its own
- K130043: Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System (2013), 2 descendants of its own
- K140205: Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion System (2014), 1 descendant of its own
- K193361: ProCell Surgical Sponge-Blood Recovery Unit (2020), 0 descendants of its own

## Indications for use
Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System is indicated for use: AUTOTRANSFUSION 1) for the collection of autologous blood from the patient’s pleural cavity or mediastinal area for reinfusion purposes in trauma and post operative situations. CHEST DRAINAGE 2) to evacuate air and/or fluid from the chest cavity or mediastinum 3) to help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum 4) to help re-establish and maintain normal intrathoracic pressure gradients, and to facilitate complete lung re-expansion to restore normal breathing dynamics.

Source page: https://510kreport.com/device/K031554
Methodology: https://510kreport.com/methodology