Cleared Traditional

K162977 - ADVIA 2120i, ADVIA 2120

K162977 is an FDA 510(k) clearance for ADVIA 2120i, manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K162977 · Siemens Healthcare Diagnostics · Hematology device
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Aug 2017
Decision
289d
Days
Class 2
Risk

K162977 is an FDA 510(k) clearance for the ADVIA 2120i, ADVIA 2120. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Tarrytown, US). The FDA issued a Cleared decision on August 11, 2017 after a review of 289 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 Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K162977

510(k) Number K162977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2016
Decision Date August 11, 2017
Days to Decision 289 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
176d slower than avg
Panel avg: 113d · This submission: 289d
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 295
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