510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993058Substantially Equivalent

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

Pure Water, Inc., Anderson SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993058 is the FDA 510(k) clearance record for PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL, a class II device, cleared for Pure Water, Inc. on under FDA product code FIN (Tank, Holding, Dialysis). FDA records list 3 510(k) clearances for Pure Water, Inc., from to . As of , FDA records show no recalls naming K993058.

Clearance record

Decision date
Received
(133 days to decision)
Product code
FIN Tank, Holding, Dialysis
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Pure Water, Inc. 305 W. Market St., Anderson SC
510(k) summary
Summary
Third party review
No

Clearances, product code FIN

Trailing 12 months

FDA records hold no clearances under product code FIN in the trailing twelve months.

FDA records show no clearances under product code FIN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FIN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260