Cleared Traditional

COULTER CELLPREP (K021150) - FDA 510(k) Clearance

Class I Hematology device.

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

Submission Details

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.

Device Classification

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.