Cleared Traditional

K021150 - COULTER CELLPREP

K021150 is an FDA 510(k) clearance for COULTER CELLPREP, manufactured by Beckman Coulter, Inc.. The device is a Class 1 Hematology device with product code GKH cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K021150 · Beckman Coulter, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
62d
Days
Class 1
Risk

K021150 is an FDA 510(k) clearance for the COULTER CELLPREP. Classified as Apparatus, Automated Blood Cell Diluting (product code GKH), Class I - General Controls.

Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on June 11, 2002 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5240 - 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.

View all Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K021150

510(k) Number K021150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2002
Decision Date June 11, 2002
Days to Decision 62 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
51d faster than avg
Panel avg: 113d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

GKH Device Classification - Class 1, General Controls

Product Code GKH Apparatus, Automated Blood Cell Diluting
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.5240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GKH Apparatus, Automated Blood Cell Diluting

All 9
Devices cleared under the same product code (GKH) and FDA review panel - the closest regulatory comparables to K021150.
COULTER MULTI Q PREP
K935953 · Coulter Corp. · Mar 1994
COULTER MULTI-Q-PREP
K923530 · Coulter Electronics, Inc. · Oct 1992
FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM
K904795 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1990
SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM
K882767 · Toa Medical Electronics USA, Inc. · Jul 1988
AD150, AUTOMATED HEMATOLOGY DILUTOR
K852373 · Abbott Diagnostics · Jul 1985
HYCEL DILUTOR, VARIOUS MODELS/MULTI
K842747 · R&D Systems, Inc. · Oct 1984