Cleared Traditional

K033840 - CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER

K033840 is an FDA 510(k) clearance for CELLAVISION DM96 AUTOMATIC HEMATOLOGY A..., manufactured by CellaVision AB. The device is a Class 2 Hematology device with product code JOY cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K033840 · CellaVision AB · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
62d
Days
Class 2
Risk

K033840 is an FDA 510(k) clearance for the CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER. 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 February 10, 2004 after a review of 62 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K033840

510(k) Number K033840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2003
Decision Date February 10, 2004
Days to Decision 62 days
Submission Type Traditional
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
51d faster than avg
Panel avg: 113d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOY Device Classification - Class 2, Special Controls

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
Devices cleared under the same product code (JOY) and FDA review panel - the closest regulatory comparables to K033840.
IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM
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MODIFICATION TO DUET SYSTEM
K050840 · Bioview , Ltd. · Aug 2005
DUET SYSTEM
K040591 · Bioview , Ltd. · Sep 2004
DUET SYSTEM
K030192 · Bioview , Ltd. · Aug 2003
DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
K003301 · CellaVision AB · Mar 2001
SLIDESCAN
K001420 · Applied Imaging Corp. · Aug 2000
K033840 · CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER
Download PDF FDA Summary CellaVision AB