510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K964539Substantially Equivalent

Portable Series Reverse Osmosis Systems 700, 701, 702, 703, 704, 750, Mre-Nf, F800-F802, Ro Secura, Reverse Osmosis Syst

Zyzatech Water Systems, Inc., Kent WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964539 is the FDA 510(k) clearance record for PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST, a class II device, cleared for Zyzatech Water Systems, Inc. on under FDA product code FIP (Subsystem, Water Purification). FDA records list one 510(k) clearance for Zyzatech Water Systems, Inc. As of , FDA records show no recalls naming K964539.

Clearance record

Decision date
Received
(379 days to decision)
Product code
FIP Subsystem, Water Purification
Regulation
21 CFR 876.5665
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Zyzatech Water Systems, Inc. 7848 S. 202nd St., Kent WA
510(k) summary
Summary
Third party review
No

Clearances, product code FIP

Trailing 12 months
1 clearance under product code FIP in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FIP, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260