# K982231: Statusflow

- Pathway: 510(k) (Special)
- Applicant: R&D Systems, Inc.
- Decided: Jul 20, 1998 after 25 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920997 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961610: R & D Systems' Whole Blood Flow Control, (R & D - WBFC), R&D Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K150815: BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit (2015), 0 descendants of its own

## Recalls of this device
- Jul 18, 2014 · Class III · Z-2233-2014: The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be 2014-09-02

## Indications for use
StatusFlow" is intended as a complete process control for immunophenotyping by flow cytometry. It is a control for antibody staining, RBC lysis, instrument set-up, instrument performance and data analysis.

Source page: https://510kreport.com/device/K982231
Methodology: https://510kreport.com/methodology