510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041163Substantially Equivalent

Isopure Complete Water System for Hemodialysis, Md 400 and Md 600 Series

Isopure Corp, Simpsonville KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K041163 is the FDA 510(k) clearance record for ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES, a class II device, cleared for Isopure, Corp. on under FDA product code FIP (Subsystem, Water Purification). FDA records list 5 510(k) clearances for Isopure, Corp., from to . As of , FDA records show one recall naming K041163.

Clearance record

Decision date
Received
(157 days to decision)
Product code
FIP Subsystem, Water Purification
Regulation
21 CFR 876.5665
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Isopure, Corp. 129 Citizens Blvd., Simpsonville KY
510(k) summary
Statement
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