FKJ

Filter, Blood, Dialysis

Product code: FKJ
Device name: Filter, Blood, Dialysis
Device class: Class 2
21 CFR: 21 CFR 876.5820
Medical specialty: Gastroenterology, Urology
Marketing pathway: 510(K)
Flag: Life-sustaining / life-supporting
510(k) clearances (last 3 years): 1
Summaries archived here: 1 (direct download)
510(k) clearances (all years, FDA): 5 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-03-17.

Number	Decision date	Applicant	Device name	Summary
K253863	2026-03-17	Serim Research	GUARDIAN Quick Dip Residual Chlorine (5212)	PDF

1 summaries are archived here for direct download.

Official FDA classification page: FKJ

Classification and pathway per current FDA publications. Data from openFDA (CC0).