Servator M SALF Solution

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K211842 ↗

FDA Product Code

KDL

Device Class

Class II

Regulation

21 CFR Part 876.5880

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• 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

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

  Class II

  CE/MDR FDA 510(k) K170150 Active Cleared 20 Oct 2017

• What clinical specialties is the Servator M SALF Solution intended for use in, and why does this matter for my practice?

  The Servator M SALF Solution is authorized for use in both urology and gastroenterology settings, as indicated by its advisory committee classification (GU) and medical specialty description. This matters because the device is specifically designed for perfusion-based preservation of kidneys, which is a critical step in organ transplantation procedures. While primarily used in urology for kidney transplantation, its inclusion in gastroenterology may relate to procedural support or cross-disciplinary training environments where organ preservation techniques are relevant.

• Is the Servator M SALF Solution reusable, or is it meant for single-use only? How does this affect storage and handling?

  The Servator M SALF Solution is intended for single-use only, as explicitly stated in the device description. This means each kit must be discarded after one use to maintain sterility and safety. Since it is sterile and pyrogen-free, proper storage between 2°C and 25°C (35.6°F–77°F) is critical to preserve its integrity. Avoid refrigeration below 2°C, as this could compromise the solution’s effectiveness for hypothermic perfusion.

• What temperature range should I use during perfusion, and why does this matter for kidney viability?

  The Servator M SALF Solution is designed for perfusion at 5°C, though a range of 4°C–8°C is acceptable. Maintaining this controlled hypothermic environment is essential because it slows metabolic activity in the kidney, reducing cellular damage during transport and storage. This preserves organ viability, ensuring the kidney remains suitable for transplantation when it reaches the recipient. Deviating from this range may risk compromising the organ’s condition.

• Are there multiple sizes or models of the Servator M SALF Solution, and how do I determine which one to use?

  The provided data lists multiple registration numbers (e.g., 3007685782, 3010877980, etc.), which typically correspond to different kit configurations or sizes for varying kidney perfusion needs. While exact specifications (e.g., tubing length, chamber volume) aren’t detailed here, these variations likely accommodate different organ sizes or procedural workflows. Consult the manufacturer’s documentation or your procurement team to select the appropriate model based on your facility’s standard practices or the donor kidney’s characteristics.

• What regulatory pathways does the Servator M SALF Solution follow, and how does this impact its use in my facility?

  The Servator M SALF Solution is cleared under FDA 510(k) (K211842) and complies with EU MDR (Medical Device Regulation) standards. This means it has undergone rigorous review to ensure safety and effectiveness for its intended use in kidney perfusion preservation. Your facility should verify that the device meets your institution’s procurement and compliance requirements, particularly if you operate under FDA or EU regulatory frameworks. The clearance also confirms it is substantially equivalent to predicate devices, reinforcing its reliability for clinical use.