Cleared Special

K010765 - COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526

K010765 is an FDA 510(k) clearance for COULTER HMX ANALYZER, 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 30-day FDA review.

K010765 · Beckman Coulter, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
30d
Days
Class 2
Risk

K010765 is an FDA 510(k) clearance for the COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526. 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 April 13, 2001 after a review of 30 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.

View all Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K010765

510(k) Number K010765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2001
Decision Date April 13, 2001
Days to Decision 30 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
83d faster than avg
Panel avg: 113d · This submission: 30d
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 295
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K010765.
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K992875 · Sysmex Corp. · Nov 1999