Curesis Plasma Separator

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

Generic Name

Separator for therapeutic purposes, membrane automated blood cell/plasma

PMA Number

P830010 ↗

FDA Product Code

MDP

Device Class

Class III

Advisory Committee

Gastroenterology, Urology

FDA Decision

APPR Approved

PMA Supplement

S003

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• Is the Curesis Plasma Separator designed for single-use or can it be reused in a clinical setting?

  The Curesis Plasma Separator is supplied as a reusable medical instrument. Since it is intended for therapeutic blood separation, it requires proper sterilization and maintenance between uses to ensure safety and functionality, as outlined in its FDA-authorized design.

• What types of clinical settings is the Curesis Plasma Separator intended for?

  The device is specifically designed for use in clinical settings such as hospitals and blood banks, where plasma separation for therapeutic applications is required. Its automated design supports controlled, high-volume processing of blood components.

• How is the Curesis Plasma Separator regulated by the FDA?

  The Curesis Plasma Separator holds an FDA Premarket Approval (PMA) under the designation P830010, confirming its compliance with regulatory standards for therapeutic blood separation systems. It falls under device class U, reflecting its role in isolating plasma while retaining cellular elements.

• What does the device separate, and what remains in the blood after processing?

  The Curesis Plasma Separator automates the separation of blood into plasma (for therapeutic use) and cellular components, including red blood cells and platelets. The device is engineered to retain these cells while isolating plasma efficiently for further medical applications.

• Are there multiple models or configurations of the Curesis Plasma Separator available?

  The device data lists multiple FEI numbers (e.g., 1450662, 1219343, etc.), which may correspond to different models or variants of the Curesis Plasma Separator. These identifiers suggest variations in design or functionality, though specific differences (e.g., capacity, features) would require direct consultation with the manufacturer.