# K120953: Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion System

- Pathway: 510(k) (Traditional)
- Applicant: Tlelflex Medical, Inc.
- Decided: Dec 10, 2012 after 255 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: 3 generations back to K801043 (1980). 10 ancestors in all.
3 later devices descend 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)
- K031554: S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System, Genzyme Biosurgery (2003) Summary page 8.
- K962856: Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100, and S-2200 with Model S-100 Autotr, Deknatel, Inc. (1996) Summary page 3.

## Most influential descendants
- 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
AUTOTRANSFUSION 1. For the collection of autologuous blood fiom the patient's pleural cavity or mediastinal area for reinfusion purposes in trauima and post-operative situations CHEST DRAINAGE 1. To evacuate air and/or fluid from the chest cavity or mediastinum 2. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. 3. To help re-establish and maintain normal intra-thoracic pressure gradients. 4. To facilitate complete lung re-expansion to restore normal breathing dynamics. The Pleur-evac® Autotransfusion Bag is indicated as a sterile, single use device used for collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac ®R System. The fluid path is non-pyrogemc.

Source page: https://510kreport.com/device/K120953
Methodology: https://510kreport.com/methodology