Cleared Special

K022161 - MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632

K022161 is an FDA 510(k) clearance for MODIFICATION TO COULTER LH 750 HEMATOLO..., manufactured by Beckman Coulter, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Special 510(k) pathway after a 26-day FDA review.

K022161 · Beckman Coulter, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
26d
Days
Class 2
Risk

K022161 is an FDA 510(k) clearance for the MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on July 29, 2002 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K022161

510(k) Number K022161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2002
Decision Date July 29, 2002
Days to Decision 26 days
Submission Type Special
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
87d faster than avg
Panel avg: 113d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

GKZ Device Classification - Class 2, Special Controls

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

All 380
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K022161.
PENTRA 80
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IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ
K022528 · Iq Corp. · Sep 2002
PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120
K022200 · Abx Diagnostics · Jul 2002
SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I
K021241 · Sysmex Corporation of America · Jun 2002
HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY
K020496 · Sysmex Corporation of America · Apr 2002
K022161 · MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
Download PDF FDA Summary Beckman Coulter, Inc.