Cleared Special

CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 (K092868) - FDA 510(k) Clearance

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

K092868 · CellaVision AB · Hematology device
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Nov 2009
Decision
63d
Days
Class 2
Risk

K092868 is an FDA 510(k) clearance for the CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127. Classified as Device, Automated Cell-locating (product code JOY), Class II - Special Controls.

Submitted by CellaVision AB (Fridley, US). The FDA issued a Cleared decision on November 20, 2009 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5260 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all CellaVision AB devices

Submission Details

510(k) Number K092868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2009
Decision Date November 20, 2009
Days to Decision 63 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 113d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JOY Device, Automated Cell-locating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5260
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 - JOY Device, Automated Cell-locating

All 34
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