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PERF-GEN Pulsatile Perfusion Solution

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121736

by Waters Medical Systems, LLC

Identifiers

510(k) Number
K121736 FDA 510(k)
FDA Product Code
KDL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5880 FDA 510(k)
Regulation Number
876.5880 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The PERF-GEN Pulsatile Perfusion Solution is a sterile, non-pyrogenic, non-toxic perfusion medium designed for in-vitro flushing and continuous hypothermic machine perfusion of explanted kidneys. Classified as a perfusion set for kidney preservation, it maintains organ viability by circulating a cooled solution through the vascular system, facilitating oxygen and substrate delivery while removing cellular debris.

This solution is supplied as a single-use, disposable device intended for use with a continuous perfusion machine to preserve kidneys during the interval between donor removal and transplantation. It is regulated under FDA 510(k) clearance (K121736) and falls under device classification II (KDL), adhering to hypothermic preservation protocols for renal grafts. Storage and handling follow sterile, non-pyrogenic standards to ensure compatibility with perfusion systems.

Frequently asked questions

What is the PERF-GEN Pulsatile Perfusion Solution specifically designed to do for kidney preservation?

The PERF-GEN Pulsatile Perfusion Solution is designed to maintain kidney viability during the period between organ removal and transplantation by circulating a cooled, sterile perfusion medium through the vascular system. It delivers oxygen and nutrients while removing cellular debris, supporting continuous hypothermic machine perfusion—an advanced method to extend organ preservation time.

Is the PERF-GEN Pulsatile Perfusion Solution intended for single-use or can it be reused?

The PERF-GEN Pulsatile Perfusion Solution is explicitly supplied as a single-use, disposable device. This design ensures sterility and non-pyrogenic integrity, which are critical for safe and effective perfusion of explanted kidneys without risk of contamination or cross-infection.

How should the PERF-GEN Pulsatile Perfusion Solution be stored to ensure proper functionality?

The solution must be stored under sterile, non-pyrogenic conditions to maintain compatibility with perfusion systems. While the exact storage instructions aren’t detailed here, adherence to standard sterile handling protocols—such as refrigeration if required and protection from contamination—is implied to preserve its integrity for use with continuous perfusion machines.

What types of perfusion machines is the PERF-GEN Pulsatile Perfusion Solution compatible with?

The PERF-GEN Pulsatile Perfusion Solution is intended for use exclusively with continuous perfusion machines designed for hypothermic preservation of renal grafts. It is not compatible with manual or non-pulsatile systems, as its formulation relies on pulsatile circulation to effectively deliver nutrients and remove waste from the organ.

Are there different sizes or models of the PERF-GEN Pulsatile Perfusion Solution, or is it a uniform formulation?

The data lists multiple FEI numbers (e.g., 3007685782, 3010877980), which typically correspond to different lot or batch identifiers rather than distinct sizes or models. This suggests the solution itself is standardized in formulation but may be packaged or distributed in varying quantities or configurations for different perfusion setups or clinical needs.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF RM4® Pulsatile Perfusion Solution - wtrs.com, PERF-GEN PULSATILE PERFUSION SOLUTION - Innolitics, Our technology - IGL Group

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Waters Medical Systems, LLC

Sources (1)

  • FDA 510(k) K121736 24 fields · synced Sep 18, 2026