Cleared Traditional

K001043 - KAWASUMI LABORATORY BLOOD DRAWING KIT

K001043 is an FDA 510(k) clearance for KAWASUMI LABORATORY BLOOD DRAWING KIT, manufactured by Kawasumi Laboratories America, Inc.. The device is a Class 2 Hematology device with product code KSB cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K001043 · Kawasumi Laboratories America, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
49d
Days
Class 2
Risk

K001043 is an FDA 510(k) clearance for the KAWASUMI LABORATORY BLOOD DRAWING KIT. Classified as Set, Transfer (blood/plasma) (product code KSB), Class II - Special Controls.

Submitted by Kawasumi Laboratories America, Inc. (Tampa, US). The FDA issued a Cleared decision on May 19, 2000 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9875 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K001043

510(k) Number K001043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2000
Decision Date May 19, 2000
Days to Decision 49 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 113d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KSB Device Classification - Class 2, Special Controls

Product Code KSB Set, Transfer (blood/plasma)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9875
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - KSB Set, Transfer (blood/plasma)

Devices cleared under the same product code (KSB) and FDA review panel - the closest regulatory comparables to K001043.
Kawasumi Laboratories Blood Drawing Kit (BDK) System
K172957 · Kawasumi Laboratories, Inc. · Sep 2018
ALPHA PLASMA TRANSFER SET
K820447 · Alpha Therapeutic Corp. · Apr 1982
SUPER-SPIKE TRANSFER SET
K802940 · Geneva Laboratories, Inc. · Jan 1981
FLU-VEN TK-2
K791130 · Venospital, Inc. · Sep 1979
FLU VEN TR-1
K791131 · Venospital, Inc. · Sep 1979
K001043 · KAWASUMI LABORATORY BLOOD DRAWING KIT
Download PDF FDA Summary Kawasumi Laboratories…