# K071681: Cytomics FC 500 MPL Flow Cytometer, Model # 626554

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Oct 4, 2007 after 107 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922745 (1993). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030828: Tetracxp System (Software and System Guide), Beckman Coulter, Inc. (2003) Summary page 1.

## Most influential descendants
- K182886: Cytomics FC 500 Series (MPL or MCL) Flow Cytometer (2019), 0 descendants of its own

## Recalls of this device
- Jan 12, 2018 · Class I · Z-0471-2019: A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact p
- Jun 29, 2007 · Not classified · Z-0958-2008: Data generation error: If the cytosettings is not refreshed or restarted during data importation, the output will include old and new data.

## Indications for use
The Cytomics FC 500 MPL is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file.

Source page: https://510kreport.com/device/K071681
Methodology: https://510kreport.com/methodology