Cleared Traditional

K141681 - SYSMEX XN SERIES

K141681 is an FDA 510(k) clearance for SYSMEX XN SERIES, manufactured by Sysmex America, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K141681 · Sysmex America, Inc. · Hematology device
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Dec 2014
Decision
165d
Days
Class 2
Risk

K141681 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 December 5, 2014 after a review of 165 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 Sysmex America, Inc. devices

FDA 510(k) Submission Details - K141681

510(k) Number K141681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2014
Decision Date December 05, 2014
Days to Decision 165 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
52d slower than avg
Panel avg: 113d · This submission: 165d
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 267
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K141681.
PENTRA XLR
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K143577 · Sysmex America, Inc. · Oct 2015
ABX MICROS ES 60 CT
K141161 · HORIBA ABX SAS · Dec 2014
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
SYSMEX XN-SERIES
K112605 · Sysmex America, Inc. · Oct 2012