# K092116: Easycell Cell Locator

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corp.
- Decided: May 12, 2010 after 302 days
- Product code: JOY (Device, Automated Cell-Locating)
- Device class: 2
- Regulation: 21 CFR 864.5260
- Recalls of this device: none
- 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.
3 later devices descend from it; 1 cites it directly.
0 of 7 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
- 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
- K243144: X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application (2025), 0 descendants of its own

## Indications for use
The EasyCell is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in vitro diagnostic use only. For professional use only.

Source page: https://510kreport.com/device/K092116
Methodology: https://510kreport.com/methodology