510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K993520Substantially Equivalent

H20nly Complete Water Purification System for Hemodialysis

Serv-A-Pure Co., Bay City MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993520 is the FDA 510(k) clearance record for H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS, a class II device, cleared for Serv-A-Pure Co. on under FDA product code FIP (Subsystem, Water Purification). FDA records list one 510(k) clearance for Serv-A-Pure Co. As of , FDA records show no recalls naming K993520.

Clearance record

Decision date
Received
(198 days to decision)
Product code
FIP Subsystem, Water Purification
Regulation
21 CFR 876.5665
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Serv-A-Pure Co. 1101 Columbus Ave., Bay City MI
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