Cleared Dual Track

K240402 - Cito CBC System

K240402 is an FDA 510(k) clearance for Cito CBC System, manufactured by Cytochip, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Dual Track 510(k) pathway after a 360-day FDA review.

K240402 · Cytochip, Inc. · Hematology device
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Feb 2025
Decision
360d
Days
Class 2
Risk

K240402 is an FDA 510(k) clearance for the Cito CBC System. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Cytochip, Inc. (Irvine, US). The FDA issued a Cleared decision on February 3, 2025 after a review of 360 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Cytochip, Inc. devices

FDA 510(k) Submission Details - K240402

510(k) Number K240402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2024
Decision Date February 03, 2025
Days to Decision 360 days
Submission Type Dual Track
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
247d slower than avg
Panel avg: 113d · This submission: 360d
Pathway characteristics

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 K240402.
Sysmex XR-Series (XR-10) Automated Hematology Analyzer
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Alinity h-series System
K243283 · Abbott Laboratories · Feb 2025
UniCel DxH 900 Coulter Cellular Analysis System
K240252 · Beckman Coulter, Inc. · Jul 2024
Yumizen H2500
K232946 · HORIBA ABX SAS · May 2024
HemoScreen Hematology Analyzer
K240636 · Pixcell Medical Technologies · May 2024