Haemonetics Cell Saver Elite/Elite+ Autotransfusion System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162423 FDA 510(k)
- FDA Product Code
- CAC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5830 FDA 510(k)
- Regulation Number
- 868.5830 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Haemonetics Cell Saver Elite/Elite+ Autotransfusion System is an Apparatus, Autotransfusion designed to recover, process, and reinfuse a patient’s own blood during surgical procedures. It functions by centrifuging blood to separate red blood cells, plasma, and other components, allowing for the collection and reinfusion of red blood cells to reduce the need for allogeneic transfusions. This system is intended for use in medium to high blood loss scenarios, supporting intraoperative and postoperative autotransfusion.
The device is supplied as a reusable system and is intended for use in hospital operating rooms and surgical suites. It requires sterile preparation and is regulated under FDA 510(k) clearance (K162423) with a classification of Class II. The system includes multiple components and is designed for compatibility with standard surgical procedures, adhering to regulation number 868.5830. No specific MRI safety information is provided, and the system is not intended for single-use applications.
Frequently asked questions
What types of surgical procedures is the Haemonetics Cell Saver Elite/Elite+ designed to support during blood recovery and reinfusion?
The Haemonetics Cell Saver Elite/Elite+ is specifically designed for medium to high blood loss scenarios during surgical procedures, enabling intraoperative and postoperative autotransfusion. It is intended for use in hospital operating rooms and surgical suites where patients may require significant blood volume recovery, such as in orthopedic, cardiac, or trauma surgeries. The system helps reduce reliance on allogeneic transfusions by processing and reinfusing the patient’s own red blood cells.
Is the Haemonetics Cell Saver Elite/Elite+ system single-use or reusable, and what does this mean for maintenance and cost?
The Haemonetics Cell Saver Elite/Elite+ is a reusable system, meaning it is designed for repeated use across multiple procedures after proper cleaning, sterilization, and maintenance. This approach reduces per-procedure costs compared to single-use devices and allows for long-term investment in the technology. However, it requires adherence to strict sterilization protocols and regular upkeep to ensure safety and performance.
How is the device prepared for use in the operating room, particularly regarding sterility?
Since the Haemonetics Cell Saver Elite/Elite+ is a reusable system, it must be thoroughly cleaned and sterilized before each use to maintain sterility. The device’s components are not pre-sterilized as single-use items would be, so hospitals must follow established protocols—such as autoclaving or chemical sterilization—to ensure a sterile field during surgical procedures. This preparation is critical for preventing contamination and ensuring patient safety.
What regulatory pathway does the Haemonetics Cell Saver Elite/Elite+ follow, and how does this affect its use in clinical settings?
The Haemonetics Cell Saver Elite/Elite+ was cleared through the FDA’s 510(k) process, specifically under clearance number K162423, and is classified as a Class II device. This means it has undergone evaluation by the FDA to demonstrate substantial equivalence to a previously cleared device, ensuring it meets safety and effectiveness standards. Clinically, this clearance allows hospitals to use the system with confidence in its regulatory compliance, though individual institutions must still follow manufacturer guidelines and internal protocols for safe operation.
Are there specific storage requirements for the Haemonetics Cell Saver Elite/Elite+ system between uses?
While the provided data does not specify detailed storage conditions, reusable medical devices like the Haemonetics Cell Saver Elite/Elite+ generally require protection from dust, moisture, and physical damage when not in use. Manufacturers typically recommend storing components in a clean, dry environment, away from direct sunlight or extreme temperatures, to preserve their integrity and functionality. Hospitals should refer to the manufacturer’s instructions for precise storage guidelines to ensure longevity and readiness for subsequent procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cell Saver® Elite®+ | Haemonetics® Hospital Solutions, Haemonetics - Wikipedia, Cell Saver® Elite®+ | Haemonetics® Hospital Solutions, Haemonetics – Wikipedia, Haemonetics Cell Saver Elite+ Autotransfusion System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162423 | Class II | Active |
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Manufacturer
- Manufacturer
- Haemonetics Corporation
Sources (1)
- FDA 510(k) K162423 24 fields · synced Sep 19, 2026