510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K993806Substantially Equivalent

Dialguard Endotoxin Removal Device

Clarigen, Inc., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993806 is the FDA 510(k) clearance record for DIALGUARD ENDOTOXIN REMOVAL DEVICE, a class II device, cleared for Clarigen, Inc. on under FDA product code FIP (Subsystem, Water Purification). FDA records list one 510(k) clearance for Clarigen, Inc. As of , FDA records show no recalls naming K993806.

Clearance record

Decision date
Received
(279 days to decision)
Product code
FIP Subsystem, Water Purification
Regulation
21 CFR 876.5665
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Clarigen, Inc. 5922 Farnsworth Ct., Carlsbad CA
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