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

Insert, Pump, Blood

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

FKL is the FDA product code for Insert, Pump, Blood, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
FKL
Device name
Insert, Pump, Blood
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
1
Ingested recalls
0

Clearances, product code FKL

By decision year
1 clearance under product code FKL with a decision year between 1985 and 1985, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FKL by decision year
YearClearances
19851

Applicants with the most clearances

Product code FKL
Applicants holding the most 510(k) clearances under product code FKL
ApplicantClearances
bioMerieux, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code FKL.