# K953302: Facs Loader System

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Immunocytometry Systems
- Decided: Nov 20, 1995 after 129 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: 1 generation back to K880636 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913192: Simultest (TM) Imk-Lymphocyte, Bd Becton Dickinson Vacutainer Systems Preanalytic (1992) Summary page 1.
- K923790: Facsort Flow Cytometer, Becton Dickinson Immunocytometry Systems (1993) Summary page 1.
- K880636: Reticcount Software, Bd Becton Dickinson Vacutainer Systems Preanalytic (1988) Summary page 1.

## Indications for use
The FACS Loader is intended for use as an accessory to the Becton Dickinson family of flow cytometers for the purpose of handling prepared blood samples for introduction to the cytometer. It is used in applications for immunophenotyping and reticulocyte enumeration.

Source page: https://510kreport.com/device/K953302
Methodology: https://510kreport.com/methodology