# K963098: Pleur-Evac Shara Plus Model S-2150/Continuous Reinfusion Autotransfusion System (S-100)

- Pathway: 510(k) (Traditional)
- Applicant: Deknatel, Inc.
- Decided: Nov 8, 1996 after 91 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.
No later device cites it as a predicate yet.
0 of 8 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.

## Indications for use
The Pleur-evac Sahara Plus Model S-2150 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/K963098
Methodology: https://510kreport.com/methodology