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

Separator, Automated, Blood Cell And Plasma, Therapeutic

Unknown
FDA source (opens on fda.gov)

LKN is the FDA product code for Separator, Automated, Blood Cell And Plasma, Therapeutic. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 12 recalls.

Classification record

Product code
LKN
Device name
Separator, Automated, Blood Cell And Plasma, Therapeutic
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
27
Ingested recalls
12

Clearances, product code LKN

By decision year
27 clearances under product code LKN with a decision year between 1983 and 2019, 2018 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LKN by decision year
YearClearances
19832
19851
19881
19891
19901
19911
19931
19962
20051
20061
20071
20101
20122
20132
20141
20152
20161
20183
20192

Applicants with the most clearances

Product code LKN
Applicants holding the most 510(k) clearances under product code LKN
ApplicantClearances
Terumobct, Inc.7
Terumo BCT, Ltd4
Cobe Laboratories, Inc.2
Fenwal Inc2
Fresenius Medical Care Renal Therapies Group, LLC2
Fresenius USA, Inc.2
Apheresis Technologies, Inc.1
Cryosan, Inc.1
Fresenius Kabi AB1
Fresenius Kabi USA, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order