S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K031554 ↗

FDA Product Code

CAC

Device Class

Class II

Regulation

21 CFR Part 868.5830

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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• What clinical scenarios is the S-1150 Pleur-Evac Sahara Plus designed to support during autotransfusion procedures?

  The S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System is specifically designed for intraoperative or postoperative use in anesthesiology settings. It is intended for trauma cases or postoperative scenarios where blood needs to be collected from the pleural cavity or mediastinal area and reinfused back into the patient. The closed-system design ensures sterile handling of autologous blood, minimizing contamination risks during the procedure.

• How is the S-1150 Pleur-Evac Sahara Plus system supplied, and what does this mean for its usability?

  The system is supplied as a single-use, sterile, and non-pyrogenic device, which means it is intended for one-time use only and does not require reprocessing. This ensures patient safety by preventing cross-contamination and maintaining sterility, as well as simplifying storage and handling protocols before use.

• Does the S-1150 Pleur-Evac Sahara Plus require a water-based drainage system, and how does it function instead?

  No, the S-1150 Pleur-Evac Sahara Plus does not require a water-based drainage system. Instead, it operates using dry suction and dry seal mechanisms, which streamline the evacuation of air and fluid from the chest cavity while simultaneously reinfusing collected blood back into the patient.

• What storage and handling guidelines should be followed to maintain the integrity of the S-1150 Pleur-Evac Sahara Plus before use?

  The system must be stored and handled according to sterile medical device protocols to preserve its integrity before use. Since it is single-use and sterile, it should remain unopened and protected from contamination until ready for deployment in a clinical setting.

• What regulatory pathway was followed for the FDA clearance of the S-1150 Pleur-Evac Sahara Plus, and what does this classification mean for its oversight?

  The S-1150 Pleur-Evac Sahara Plus received FDA clearance through a traditional 510(k) pathway, specifically under the classification of an Apparatus, Autotransfusion, and is classified as a Class II medical device. This means it is subject to stricter regulatory controls than Class I devices but does not require the same rigorous premarket approval process as Class III devices. The clearance (K031554) was granted under regulation 868.5830, ensuring it meets established safety and effectiveness standards for its intended use.