FKJ · Class II · 21 CFR 876.5820

FDA Product Code FKJ: Filter, Blood, Dialysis

Leading manufacturers include Serim Research.

5
Total
5
Cleared
81d
Avg days
1977
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 104d recently vs 76d historically

FDA 510(k) Cleared Filter, Blood, Dialysis Devices (Product Code FKJ)

5 devices
1–5 of 5
Cleared Mar 17, 2026
GUARDIAN™ Quick Dip Residual Chlorine (5212)
K253863
Serim Research
Gastroenterology & Urology · 104d

About Product Code FKJ - Regulatory Context

510(k) Submission Activity

5 total 510(k) submissions under product code FKJ since 1977, with 5 receiving FDA clearance (average review time: 81 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under FKJ have taken an average of 104 days to reach a decision - up from 76 days historically. Manufacturers should account for longer review timelines in current project planning.

FKJ devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →