Cleared Traditional

K181475 - DxH 520 Hematology Instrument

K181475 is an FDA 510(k) clearance for DxH 520 Hematology Instrument, manufactured by Beckman Coulter. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K181475 · Beckman Coulter · Hematology device
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Mar 2019
Decision
270d
Days
Class 2
Risk

K181475 is an FDA 510(k) clearance for the DxH 520 Hematology Instrument. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Beckman Coulter (Miami, US). The FDA issued a Cleared decision on March 1, 2019 after a review of 270 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Coulter devices

FDA 510(k) Submission Details - K181475

510(k) Number K181475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received June 04, 2018
Decision Date March 01, 2019
Days to Decision 270 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
157d slower than avg
Panel avg: 113d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 226
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K181475.
Sight OLO
K190898 · Sight Diagnostics , Ltd. · Nov 2019
Cytomics FC 500 Series (MPL or MCL) Flow Cytometer
K182886 · Beckman Coulter · Sep 2019
CELL-DYN Emerald 22 AL System
K190294 · Abbott Laboratories · Mar 2019
Sysmex XN-L Automated Hematology Analyzer
K182389 · Sysmex America, Inc. · Jan 2019
Athelas One
K181288 · Athelas, Inc. · Nov 2018
HemoScreen Hematology Analyzer
K180020 · Pixcell Medical Technologies, Ltd. · Oct 2018