# K963850: Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System

- Pathway: 510(k) (Traditional)
- Applicant: Deknatel, Inc.
- Decided: Apr 22, 1997 after 209 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 K801043 (1980). 7 ancestors in all.
5 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)
- K801043: E-Vax Chest Drainage System, Cardio Surgical Concepts, Inc. (1980) Summary page 1.
- K830671: Thorax-Klex Chest Drainage Unit, C.R. Bard, Inc. (1983) Summary page 1.
- K881252: Pleur-Evac (R) A6000 Adult/Pediatric Chest Drainage, Deknatel, Inc. (1988) Summary page 1.
- K905768: Pleur-Evac Chest Drainage Systems, Deknatel, Inc. (1991) Summary page 1.
- K911656: Pleur-Evac Plus Contin. Reinfus. & Autoinfus. Syst, Pfizer Hospital Products Group, Inc. (1991) Summary page 1.
- K854301: Pleur-Evac II Autotransfusion System, Deknatel, Inc. (1985) Summary page 1.
- K884844: Pleur-Evac (R) a-7002--Adult/Pediatric Drainage, Deknatel, Inc. (1989) Summary page 1.

## Most influential descendants
- K031554: S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System (2003), 4 descendants of its own
- 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
The Pleur-evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System, is a sterile, non-pyrogenic, single use, three chamber collection/reinfusion device that is intended for collection and continuous reinfusion of autologous blood. The Pleur-evac Sahara Model S-100 Autotransfusion Bag is a sterile, non-pyrogenic, single-use device, used for post-surgical collection and reinfusion of autologous blood from the thoracic cavity when attached to a Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System.

Source page: https://510kreport.com/device/K963850
Methodology: https://510kreport.com/methodology