Cleared Traditional

K112605 - SYSMEX XN-SERIES

K112605 is the FDA 510(k) clearance for SYSMEX XN-SERIES by Sysmex America, Inc.. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 408-day FDA review.

K112605 · Sysmex America, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
408d
Days
Class 2
Risk

K112605 is an FDA 510(k) clearance for the SYSMEX XN-SERIES. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Sysmex America, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on October 19, 2012 after a review of 408 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Sysmex America, Inc. devices

Submission Details

510(k) Number K112605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2011
Decision Date October 19, 2012
Days to Decision 408 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
295d slower than avg
Panel avg: 113d · This submission: 408d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 194
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K112605.
XW-100 Automated Hematology Analyzer, XW QC CHECK
K143577 · Sysmex America, Inc. · Oct 2015
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM
K140911 · Beckman Coulter, Inc. · Sep 2014
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
K120771 · Beckman Coulter, Inc. · Mar 2013
CELL-DYN EMERALD 22 SYSTEM
K110381 · Abbott Laboratories · Dec 2011
ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
K102644 · Siemens Healthcare Diagnostics · Nov 2011
BD FACS SAMPLE PREP ASSISTANT III (SPA III)
K102064 · Becton, Dickinson & CO · Mar 2011