Cleared Traditional

CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER (K033840) - FDA 510(k) Clearance

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

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

Submission Details

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.

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
Devices cleared under the same product code (JOY) and FDA review panel - the closest regulatory comparables to K033840.
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
K243144 · Scopio Labs , Ltd. · Jun 2025
AI100 with Shonit
K221309 · Sigtuple Technologies Pvt. , Ltd. · Sep 2023
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
K220013 · Scopio Labs , Ltd. · May 2022
CellaVision DC-1, CellaVision DC-1 PPA
K200595 · CellaVision AB · Oct 2020
X100 with Full Field Peripheral Blood Smear (PBS) Application
K201301 · Scopio Labs , Ltd. · Oct 2020
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
K182062 · Sysmex America, Inc. · Oct 2018