510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001043Substantially Equivalent

Kawasumi Laboratory Blood Drawing Kit

Kawasumi Laboratories America, Inc., Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001043 is the FDA 510(k) clearance record for KAWASUMI LABORATORY BLOOD DRAWING KIT, a class II device, cleared for Kawasumi Laboratories America, Inc. on under FDA product code KSB (Set, Transfer (Blood/Plasma)). FDA records list 6 510(k) clearances for Kawasumi Laboratories America, Inc., from to . As of , FDA records show no recalls naming K001043.

Clearance record

Decision date
Received
(49 days to decision)
Product code
KSB Set, Transfer (Blood/Plasma)
Regulation
21 CFR 864.9875
Device class
Class II
Review panel
Hematology
Applicant
Kawasumi Laboratories America, Inc. 5905 C Hampton Oaks Pkwy., Tampa FL
510(k) summary
Summary
Third party review
No

Clearances, product code KSB

Trailing 12 months

FDA records hold no clearances under product code KSB in the trailing twelve months.

FDA records show no clearances under product code KSB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KSB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260