Cleared Traditional

K051693 - MODIFICATION TO BAYER ADVIA 2120 HEMATO...

K051693 is an FDA 510(k) clearance for MODIFICATION TO BAYER ADVIA 2120 HEMATO..., manufactured by Bayer Healthcare, LLC. The device is a Class 2 Hematology device with product code GKL cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K051693 · Bayer Healthcare, LLC · Hematology device
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Dec 2005
Decision
167d
Days
Class 2
Risk

K051693 is an FDA 510(k) clearance for the MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Bayer Healthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on December 7, 2005 after a review of 167 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - 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 Bayer Healthcare, LLC devices

FDA 510(k) Submission Details - K051693

510(k) Number K051693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2005
Decision Date December 07, 2005
Days to Decision 167 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
54d slower than avg
Panel avg: 113d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKL Device Classification - Class 2, Special Controls

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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 - GKL Counter, Cell, Automated (particle Counter)

All 90
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K051693.
SYSMEX POCH-100I
K032677 · Sysmex America, Inc. · Feb 2004
ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD
K022331 · Bayer Diagnostics Corp. · Sep 2002
COULTER Z2 ANALYZER
K991070 · Coulter Corp. · May 1999
ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
K971998 · Bayer Corp. · Aug 1997
COULTER GEN-S SYSTEM
K962988 · Coulter Corp. · Oct 1996
RETICULOCYTE METHOD
K954607 · Bayer Corp. · Aug 1996