Cleared Traditional

CELLAVISION DM96 WITH THE BODY FLUID APPLICATION (K080595) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080595 · CellaVision AB · Hematology device
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Dec 2008
Decision
277d
Days
Class 2
Risk

K080595 is an FDA 510(k) clearance for the CELLAVISION DM96 WITH THE BODY FLUID APPLICATION. Classified as Device, Automated Cell-locating (product code JOY), Class II - Special Controls.

Submitted by CellaVision AB (Minneapolis,, US). The FDA issued a Cleared decision on December 5, 2008 after a review of 277 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5260 - 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 CellaVision AB devices

Submission Details

510(k) Number K080595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2008
Decision Date December 05, 2008
Days to Decision 277 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 113d · This submission: 277d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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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