# K033840: Cellavision DM96 Automatic Hematology Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: CellaVision AB
- Decided: Feb 10, 2004 after 62 days
- Product code: JOY (Device, Automated Cell-Locating)
- Device class: 2
- Regulation: 21 CFR 864.5260
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K925670 (1993). 2 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003301: Diffmaster Octavia Automatic Hematology Analyzer, CellaVision AB (2001) Summary page 1.
- (no number) Romanowsky stain manual light microscopic process: named in the summary without a submission number

## Most influential descendants
- K092868: Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127 (2009), 4 descendants of its own
- K092116: Easycell Cell Locator (2010), 3 descendants of its own
- K201301: X100 with Full Field Peripheral Blood Smear (PBS) Application (2020), 2 descendants of its own
- K220013: X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application (2022), 1 descendant of its own
- K200595: CellaVision DC-1, CellaVision DC-1 PPA (2020), 1 descendant of its own

## Recalls of this device
- Dec 4, 2017 · Class II · Z-2184-2018: A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.

## Indications for use
DM96 is an automated cell-locating device. DM96 automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. DM96 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.

Source page: https://510kreport.com/device/K033840
Methodology: https://510kreport.com/methodology