Cleared Traditional

K032214 - MEDONIC CA620/530 HEMATOLOGY ANALYZER

K032214 is an FDA 510(k) clearance for MEDONIC CA620/530 HEMATOLOGY ANALYZER, manufactured by Boule Medical AB. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K032214 · Boule Medical AB · Hematology device
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Jan 2004
Decision
192d
Days
Class 2
Risk

K032214 is an FDA 510(k) clearance for the MEDONIC CA620/530 HEMATOLOGY ANALYZER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Boule Medical AB (Plantation, US). The FDA issued a Cleared decision on January 29, 2004 after a review of 192 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 Boule Medical AB devices

FDA 510(k) Submission Details - K032214

510(k) Number K032214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2003
Decision Date January 29, 2004
Days to Decision 192 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 113d · This submission: 192d
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 304
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