# K162414: UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Nov 29, 2016 after 92 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K120771 (2013). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140911: Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer Coulter Cellular Analysis System, Beckman Coulter, Inc. (2014) Summary page 4.

## Most influential descendants
- K240252: UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System (2024), 0 descendants of its own

## Indications for use
The DxH Slidemaker Stainer (SMS) is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

Source page: https://510kreport.com/device/K162414
Methodology: https://510kreport.com/methodology