# K041882: Flowcare System

- Pathway: 510(k) (Traditional)
- Applicant: Pointcare Technologies, Inc.
- Decided: Nov 23, 2004 after 134 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: 3 generations back to K922745 (1993). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962988: Coulter Gen-S System, Coulter Corp. (1996) Summary page 1.
- K032342: Coulter LH 750 Hematology Analyzer, Beckman Coulter, Inc. (2003) Summary page 1.
- K011342: Coulter LH 750 Hematology Analyzer, Model 6605632, Beckman Coulter, Inc. (2001) Summary page 1.
- K990172: Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome CD45-Fitc/CD4-RD1/CD8-Ecd/CD3-PC5 Monocla, Coulter Corp. (1999) Summary page 1.

## Most influential descendants
- K072869: Pointcare Now System (2008), 0 descendants of its own

## Indications for use
The FlowCare System is an automated immune hematology system intended for in vitro diagnostic use in the direct enumeration of White Blood Cell populations and certain T-lymphocyte subsets from human whole blood. Whole blood samples can be analyzed with the FlowCare™ System for the following parameters: * White Blood Cell Count * Lymphocyte Percentage (of White Blood Cells) * Lymphocyte Number * CD4 T-Lymphocyte Count * CD4 Percentage (of total Lymphocytes) The FlowCare System and its methods for immune hematology analysis are intended for in vitro diagnostic use in clinical laboratory settings.

Source page: https://510kreport.com/device/K041882
Methodology: https://510kreport.com/methodology