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

Set, Transfer (Blood/Plasma)

21 CFR 864.9875 / Hematology
FDA source (opens on fda.gov)

KSB is the FDA product code for Set, Transfer (Blood/Plasma), a class II device type, regulated under 21 CFR 864.9875. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
KSB
Device name
Set, Transfer (Blood/Plasma)
Regulation
21 CFR 864.9875
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
11

Clearances, product code KSB

By decision year
6 clearances under product code KSB with a decision year between 1979 and 2018, 1979 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KSB by decision year
YearClearances
19792
19811
19821
20001
20181

Applicants with the most clearances

Product code KSB
Applicants holding the most 510(k) clearances under product code KSB
ApplicantClearances
Venospital, Inc.2
Alpha Therapeutic Corp.1
Geneva Laboratories, Inc.1
Kawasumi Laboratories America, Inc.1
Kawasumi Laboratories Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order