Cryomax(Tm)

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

Generic Name

Separator, automated, blood cell and plasma, therapeutic

PMA Number

P820002 ↗

FDA Product Code

LKN

Device Class

U

Advisory Committee

Gastroenterology, Urology

FDA Decision

APPR Approved

PMA Supplement

S001

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  Class II

  FDA 510(k) K905851 Active Cleared 5 Apr 1991

• Lifeport Attachable System W/Inducer Kit Lps 5555

  Class II

  FDA 510(k) K915273 Active Cleared 7 Jul 1993

• Stratofuse Syringe Piggyback Pump 1030

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• Strato Life Port II Dual Lumen Port/Modification

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• Infuse-A-Cath Silicone Central Venous Catheter

  Class II

  FDA 510(k) K921751 Active Cleared 7 Jul 1993

• Life-Port Implantable Vascular Access

  Class II

  FDA 510(k) K853827 Active Cleared 13 Nov 1986

See all devices from Strato Medical Corp. →

• What clinical processes is the Cryomax™ designed to support in blood component therapy?

  The Cryomax™ is an automated therapeutic separator intended for isolating plasma from whole blood, which is essential for processes like cryopreservation or preparing plasma for medical treatments. It streamlines the separation of blood cells and plasma, enabling further therapeutic use in clinical settings.

• Is the Cryomax™ a single-use device, or is it meant for repeated clinical use?

  The Cryomax™ is explicitly described as a reusable medical instrument, meaning it is designed for multiple uses in clinical settings with proper maintenance and adherence to sterile protocols. It is not intended for single-use applications.

• What regulatory pathway was followed for the Cryomax™, and where is it authorized for use?

  The Cryomax™ received FDA Premarket Approval (PMA P820002) and is authorized for distribution in the United States under product code LKN. This approval ensures it meets regulatory standards for therapeutic blood cell and plasma separation.

• Does the Cryomax™ have any special handling requirements beyond standard sterile protocols?

  While the Cryomax™ is not designated as MRI-safe or single-use, its clinical application requires adherence to sterile protocols as dictated by its use in blood separation. Proper maintenance is also necessary to ensure its continued functionality and safety in therapeutic settings.