Servator B SALF Solution
by S.A.L.F. Spa EUDAMED510(k)
Active
510(k) K180481
Overview
The Servator B SALF Solution is a sterile, non-pyrogenic perfusion system designed for kidney preservation. Classified as a perfusion system for kidney organs, it is intended to facilitate the hypothermic storage and transport of isolated kidneys prior to transplantation, maintaining organ viability during this critical period.
This solution is supplied as a single-use sterile formulation, intended for use between 2°C and 6°C (36°F–43°F). It is administered via perfusion to flush and preserve kidneys immediately before or after removal from a donor. Authorized under FDA 510(k) clearance (K180481) and MDR compliance, it adheres to regulatory standards for organ preservation solutions, ensuring compatibility with clinical protocols in transplantation settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK180481 | Date29 Jun 2018 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KDN
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5880
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from S.A.L.F. Spa
Questions
What is the primary purpose of the Servator B SALF Solution in clinical settings?
The Servator B SALF Solution is designed specifically for kidney preservation during transplantation procedures. It is used as a sterile, non-pyrogenic perfusion system to flush and maintain isolated kidneys under hypothermic conditions (between 2°C and 6°C) during storage and transport, ensuring organ viability until transplantation.
Is the Servator B SALF Solution intended for single-use or repeated use, and why?
The Servator B SALF Solution is supplied as a single-use sterile formulation. This is explicitly stated in the product description to ensure sterility and prevent contamination risks, which is critical for organ preservation and transplantation safety.
What temperature range is required for storing and using the Servator B SALF Solution?
The Servator B SALF Solution must be stored and used within a temperature range of 2°C to 6°C (36°F–43°F). This controlled hypothermic environment is essential for maintaining kidney viability during perfusion and transport prior to transplantation.
How is the Servator B SALF Solution regulated, and what does this mean for clinicians?
The Servator B SALF Solution is authorized under FDA 510(k) clearance (K180481) and complies with MDR (Medical Device Regulation) standards. This means it has undergone regulatory review to ensure safety and effectiveness for its intended use in kidney perfusion, providing clinicians with confidence in its clinical suitability for organ preservation protocols.
Are there different sizes or models of the Servator B SALF Solution, and if so, how are they specified?
The provided data does not specify distinct sizes or models of the Servator B SALF Solution beyond its classification as a perfusion system for kidney organs. The product is described as a single-use sterile formulation without additional variations mentioned, so it is likely supplied as a standardized solution for general kidney preservation applications.