Product code KSB— Hematology

ALPHA PLASMA TRANSFER SET

Classification name: Set, Transfer (Blood/Plasma)
Device class: Class 2
Regulation: 21 CFR 864.9875
Advisory panel: Hematology
Total cleared: 6
First cleared: 1979-09-04
Most recent: 2018-09-28

Market context for product code KSB

FDA has cleared 6 devices under product code KSB between 1979 and 2018, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20181 clearance
20001 clearance
19821 clearance
19811 clearance
19792 clearances

Top applicants under product code KSB

Venospital, Inc.2 clearances
Kawasumi Laboratories, Inc.1 clearance
Kawasumi Laboratories America, Inc.1 clearance
Geneva Laboratories, Inc.1 clearance
Alpha Therapeutic Corp.1 clearance

Recent clearances under product code KSB

K172957 — Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc.·2018-09-28
K001043 — KAWASUMI LABORATORY BLOOD DRAWING KITKawasumi Laboratories America, Inc.·2000-05-19
K820447 — ALPHA PLASMA TRANSFER SETAlpha Therapeutic Corp.·1982-04-14
K802940 — SUPER-SPIKE TRANSFER SETGeneva Laboratories, Inc.·1981-01-15
K791130 — FLU-VEN TK-2Venospital, Inc.·1979-09-04
K791131 — FLU VEN TR-1Venospital, Inc.·1979-09-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.