510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253863Substantially Equivalent

GUARDIAN™ Quick Dip Residual Chlorine (5212)

Serim Research Corp., Elkhart IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253863 is the FDA 510(k) clearance record for GUARDIAN™ Quick Dip Residual Chlorine (5212), a class II device, cleared for Serim Research on under FDA product code FKJ (Filter, Blood, Dialysis). FDA records list 31 510(k) clearances for Serim Research, from to . As of , FDA records show no recalls naming K253863.

Clearance record

Decision date
Received
(104 days to decision)
Product code
FKJ Filter, Blood, Dialysis
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Serim Research 3506 Reedy Dr., Elkhart IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FKJ

Trailing 12 months
1 clearance under product code FKJ in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FKJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260