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

Connector, Blood Tubing, Infusion T

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

FKB is the FDA product code for Connector, Blood Tubing, Infusion T, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
FKB
Device name
Connector, Blood Tubing, Infusion T
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
2
Ingested recalls
1

Clearances, product code FKB

By decision year
2 clearances under product code FKB with a decision year between 1977 and 1989, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FKB by decision year
YearClearances
19771
19891

Applicants with the most clearances

Product code FKB
Applicants holding the most 510(k) clearances under product code FKB
ApplicantClearances
Akcess Medical Products, Inc.1
Quinton, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code