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

Subsystem, Proportioning

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

FKR is the FDA product code for Subsystem, Proportioning, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
FKR
Device name
Subsystem, Proportioning
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
12
Ingested recalls
10

Clearances, product code FKR

By decision year
12 clearances under product code FKR with a decision year between 1978 and 2014, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FKR by decision year
YearClearances
19781
19802
19812
19852
20051
20061
20081
20111
20141

Applicants with the most clearances

Product code FKR
Applicants holding the most 510(k) clearances under product code FKR
ApplicantClearances
NxStage Medical Inc5
BD Becton Dickinson Vacutainer Systems Preanalytic1
Extracorporeal Medical Specialities, Inc.1
Gambro, Inc.1
Renal Systems, Inc.1
Sartorius Filters, Inc.1
Travenol Laboratories, S.A.1
Trimedyne, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code