Renapak Concentrate Mixing System

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

Full name

Renapak Concentrate Mixing Sys.

510(k) Number

K840182 ↗

FDA Product Code

FKQ

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Renal Systems, Inc. →

• What is the Renapak Concentrate Mixing System used for?

  The Renapak Concentrate Mixing System is designed for central multiple patient use in dialysis facilities, allowing for the preparation and storage of concentrates on-site to support the dialysis process by providing necessary chemical solutions.

• How is the Renapak Concentrate Mixing System supplied?

  The device is supplied as a complete system for use in dialysis settings, with various models available to meet different facility needs, though specific size options are not detailed in the provided information.

• What is the regulatory status of the Renapak Concentrate Mixing System?

  The Renapak Concentrate Mixing System is regulated under FDA 510(k) clearance with product code FKQ, classified as a Class 2 device, and received FDA clearance in 1984 with decision code SESE indicating substantial equivalence.

• In which medical specialties is the Renapak Concentrate Mixing System used?

  The system is intended for use in gastroenterology and urology applications, as indicated by its review advisory committee designation GU and medical specialty description in the FDA registration.