510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992793Substantially Equivalent

Sodium Bicarbonate Mixing/delivery System, and the Concentrate Delivery System

Better Water, Inc., Smyrna TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992793 is the FDA 510(k) clearance record for SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM, a class II device, cleared for Better Water, Inc. on under FDA product code FIN (Tank, Holding, Dialysis). FDA records list 5 510(k) clearances for Better Water, Inc., from to . As of , FDA records show no recalls naming K992793.

Clearance record

Decision date
Received
(89 days to decision)
Product code
FIN Tank, Holding, Dialysis
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Better Water, Inc. 698 Swan Dr., Smyrna TN
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