Acidified Storage and Distribution System With Optional Remote Fill

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

Full name

Pure Water Inc's Acidified Storage and Distribution System with Optional Remote Fill

510(k) Number

K993058 ↗

FDA Product Code

FIN

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Pure Water, Inc.'s Water Purification Systems

  Class II

  FDA 510(k) K992786 Active Cleared 24 Jan 2000

• Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System

  Class II

  FDA 510(k) K993272 Active Cleared 10 Apr 2000

• What is the Pure Water Inc's Acidified Storage and Distribution System with Optional Remote Fill intended for?

  This device is designed for the storage and distribution of acid concentrate used in hemodialysis treatment. It maintains and dispenses acidified solutions to ensure consistent formulation and delivery to patients in hemodialysis facilities. The system supports dialysis protocols and is compatible with use in gastroenterology and urology settings, as indicated by its regulatory classification and intended use description.

• Is the Pure Water Inc's Acidified Storage and Distribution System reusable or single-use?

  The device is supplied as a reusable medical device. It is engineered for repeated use in hemodialysis facilities, where it stores and distributes acid concentrate over multiple treatment cycles. Its design allows for cleaning, maintenance, and reuse in accordance with facility protocols and manufacturer guidelines, rather than being discarded after a single use.

• What regulatory pathway was used for the clearance of this device, and what is its 510(k) number?

  The device received FDA clearance through the traditional 510(k) pathway, as indicated by the authorization type FDA_510K and clearance_type Traditional. Its specific 510(k) number is K993058, with a decision date of January 24, 2000, and a decision code of SESE, confirming it was found substantially equivalent to a predicate device.

• What is the device classification and regulation number for this acidified storage and distribution system?

  The device is classified as a Class II medical device under regulation number 21 CFR 876.5820, which governs tanks, holding, dialysis. This classification is confirmed in the openfda field showing device_class=2 and regulation_number=876.5820, aligning with its intended use for storing and distributing acid concentrate in hemodialysis applications.

• What optional feature is available on this system, and how does it enhance functionality?

  The system offers an optional remote fill feature, which enhances operational flexibility by allowing the acid concentrate tank to be filled from a distance. This reduces the need for direct handling of concentrated acids near the dialysis station, improving workflow efficiency and safety in hemodialysis facilities while maintaining compatibility with standard dialysis protocols.