Cleared Dual Track

K240402 - Cito CBC System (FDA 510(k) Clearance)

Class II Hematology device cleared through the Dual Track 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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

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 378
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