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

System, Dialysate Delivery, Central Multiple Patient

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

FKQ is the FDA product code for System, Dialysate Delivery, Central Multiple Patient, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 61 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
FKQ
Device name
System, Dialysate Delivery, Central Multiple Patient
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
61
Ingested recalls
2

Clearances, product code FKQ

By decision year
61 clearances under product code FKQ with a decision year between 1976 and 2006, 1984 the highest year at 15.
Show the numbers
510(k) clearances under FDA product code FKQ by decision year
YearClearances
19761
19771
19783
19802
19815
19828
19833
198415
19859
19867
19874
19881
19891
20061

Applicants with the most clearances

Product code FKQ
Applicants holding the most 510(k) clearances under product code FKQ
ApplicantClearances
Hospal Medical Corp.7
Travenol Laboratories, S.A.5
Extracorporeal Medical Specialities, Inc.4
National Medical Care, Medical Products Div., Inc.4
Renal Systems, Inc.4
bioMerieux, Inc.2
Seratronics, Inc.2
Alan P. Kendal, Ph.D.1
Alcide Corp.1
Amuchina Intl., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code