# K092868: Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127

- Pathway: 510(k) (Special)
- Applicant: CellaVision AB
- Decided: Nov 20, 2009 after 63 days
- Product code: JOY (Device, Automated Cell-Locating)
- Device class: 2
- Regulation: 21 CFR 864.5260
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K925670 (1993). 3 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033840: Cellavision DM96 Automatic Hematology Analyzer, CellaVision AB (2004) Summary page 1.

## Most influential descendants
- K200595: CellaVision DC-1, CellaVision DC-1 PPA (2020), 1 descendant of its own
- K221309: AI100 with Shonit (2023), 0 descendants of its own
- K171655: cobas m 511 integrated hematology analyzer (2018), 0 descendants of its own
- K171315: Advanced RBC Application (2017), 0 descendants of its own

## Recalls of this device
- Oct 8, 2025 · Class II · Z-0542-2026: Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.
- 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
DM1200 is an automated cell-locating device. DM1200 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. DM1200 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/K092868
Methodology: https://510kreport.com/methodology