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)
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.

View all CellaVision AB devices

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
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 21
Devices cleared under the same product code (JOY) and FDA review panel - the closest regulatory comparables to K033840.
Advanced RBC Application
K171315 · CellaVision AB · Aug 2017
EASYCELL CELL LOCATOR
K092116 · Medica Corp. · May 2010
MODIFICATION TO DUET SYSTEM
K050840 · Bioview , Ltd. · Aug 2005
AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
K984188 · Chroma Vision Medical Systems, Inc. · Jul 1999
TRACCELL 2000 SLIDE MAPPING SYSTEM
K982786 · Accumed Intl., Inc. · Oct 1998
MICRO21 WITH URINE SEDIMENT ANALYSIS
K982301 · Triangle Biomedical Sciences, Inc. · Aug 1998