510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970674Substantially Equivalent

G.e.m. Water Systems, International

G.E.M. Water Systems, Cypress CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970674 is the FDA 510(k) clearance record for G.E.M. WATER SYSTEMS, INTERNATIONAL, a class II device, cleared for G.E.M. Water Systems on under FDA product code FIN (Tank, Holding, Dialysis). FDA records list 3 510(k) clearances for G.E.M. Water Systems, from to . As of , FDA records show no recalls naming K970674.

Clearance record

Decision date
Received
(268 days to decision)
Product code
FIN Tank, Holding, Dialysis
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
G.E.M. Water Systems 5940 Lakeshore Dr., Cypress CA
510(k) summary
Statement
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