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

Set, Dialyzer Holder

21 CFR 876.5820 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FKI is the FDA product code for Set, Dialyzer Holder, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FKI
Device name
Set, Dialyzer Holder
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code FKI

By decision year
3 clearances under product code FKI with a decision year between 1980 and 1984, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FKI by decision year
YearClearances
19801
19811
19841

Applicants with the most clearances

Product code FKI
Applicants holding the most 510(k) clearances under product code FKI
ApplicantClearances
American Bentley1
Extracorporeal Medical Specialities, Inc.1
Renal Devices, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code