Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K170150 ↗

FDA Product Code

KDL

Device Class

Class II

Regulation

21 CFR Part 876.5880

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Servator M SALF Solution

  Class II

  CE/MDR FDA 510(k) K211842 Active Cleared 20 Dec 2021

• Servator P SALF Solution with THAM

  Class II

  CE/MDR FDA 510(k) K202652 Active Cleared 19 Aug 2021

• Servator B SALF Solution

  Class II

  CE/MDR FDA 510(k) K180481 Active Cleared 29 Jun 2018

• Servator C SALF Solution

  Class II

  CE/MDR FDA 510(k) K190063 Active Cleared 14 Aug 2019

• Servator P Plus Solution

  Class II

  CE/MDR FDA 510(k) K230193 Active Cleared 21 Sep 2023

• What clinical specialties commonly use the Servator H SALF solution, and why is it relevant to them?

  The Servator H SALF solution is primarily used in urology and gastroenterology clinical settings. It is designed specifically for kidney perfusion and preservation, making it relevant to urologists who perform kidney transplants or handle donated kidneys. The sterile, single-use bags help maintain organ viability during transport and storage, which is critical for successful transplantation procedures.

• Are the Servator H SALF solution bags reusable, and how should they be stored to maintain sterility?

  The Servator H SALF solution bags are single-use only and come pre-sterilized. To maintain sterility, they must be stored in their original packaging, away from direct sunlight, extreme temperatures, and contamination. Follow standard sterile medical device storage protocols, ensuring the sealed barrier remains intact until use.

• What volume options are available for the Servator H SALF solution, and how does this affect its use?

  The Servator H SALF solution is available in two volume options: 1000 ml and 2000 ml, both in PVC-free bags. The choice depends on the clinical need—smaller volumes may suffice for shorter perfusion times or smaller organs, while the larger volume provides extended preservation capacity for longer transport or additional organ handling.

• Is the Servator H SALF solution compatible with MRI machines, and what safety considerations should be noted?

  The Servator H SALF solution does not specify MRI safety restrictions, meaning it is not explicitly labeled as MRI-compatible or unsafe. However, since it is a perfusion fluid and not an implantable device, the primary concern lies in its use near MRI environments—ensure no metallic components (e.g., clamps or connectors) are present that could interfere with imaging. Always follow facility protocols for non-MRI-labeled medical devices in MRI rooms.

• How is the regulatory status of the Servator H SALF solution determined, and what does this mean for purchasing?

  The Servator H SALF solution holds FDA 510(k) clearance and MDR compliance, confirming it meets regulatory standards for safety and effectiveness. This means it has undergone review by the FDA (via a 510(k) submission) and aligns with EU Medical Device Regulation (MDR) requirements. For purchasing, this indicates the product is legally marketable in the U.S. and EU, though local compliance with distribution laws (e.g., licensing) remains the buyer’s responsibility.