510(k) · Cleared
ClearedFlowcare System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pointcare Technologies, Inc. · GKZ Counter, Differential Cell
Cleared on Nov 23, 2004 as substantially equivalent to K962988 (Coulter Corp., 1996) and 3 other predicates after a 134-day review. Its family tree reaches back 3 generations to 1993. 2 of the 13 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Nov 23, 2004
- Review
- 134 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K922745 (1993). 11 ancestors in all, the oldest K885093 (1988). 1 later device descends from it, 1 citing it directly. 2 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK922745 Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1Coulter Immunology · 1993
- 2 generations backK963263 Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat…Coulter Corp. · 1997 · Recalled (Class I)
- 1 generation backK990172 Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat…Coulter Corp. · 1999 · Recalled (Class I)
- This deviceK041882 Flowcare SystemPointcare Technologies, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK072869 Pointcare Now SystemPointcare Technologies, Inc. · 2008 · Recalled
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K072869Pointcare Now SystemPointcare Technologies, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922745 | Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1 | Coulter Immunology | 1993 | — |
| −2 | K963263 | Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome… | Coulter Corp. | 1997 | Class I |
| −1 | K990172 | Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome… | Coulter Corp. | 1999 | Class I |
| 0 (this device) | K041882 | Flowcare System | Pointcare Technologies, Inc. | 2004 | — |
| +1 | K072869 | Pointcare Now System | Pointcare Technologies, Inc. | 2008 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 3 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GKZ device
- #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962988 | Coulter Gen-S SystemSummary page 1…ed Differential Cell Counter 3. PREDICATE DEVICES · Coulter® Gen-S Hematology Analyzer Beckman Coulter, Inc. K962988 * Coulter® LH750 Hematology Analyzer Beckman Coulter, Inc. K032342 and K01 13… | 1996 |
| * | K032342 | Coulter LH 750 Hematology AnalyzerSummary page 1…Beckman Coulter, Inc. K962988 * Coulter® LH750 Hematology Analyzer Beckman Coulter, Inc. K032342 and K01 1342 * Coulter® tetraONETM System for EPICS XL Flow Cytometry Systems Beckman Coulter,… | 2003 |
| * | K011342 | Coulter LH 750 Hematology Analyzer, Model 6605632Summary page 1…eckman Coulter, Inc. K962988 * Coulter® LH750 Hematology Analyzer Beckman Coulter, Inc. K032342 and K01 1342 * Coulter® tetraONETM System for EPICS XL Flow Cytometry Systems Beckman Coulter, Inc.… | 2001 |
| * | K990172 | Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…Summary page 1…K032342 and K01 1342 * Coulter® tetraONETM System for EPICS XL Flow Cytometry Systems Beckman Coulter, Inc. K990172 4. DEVICE DESCRIPTION The FlowCare System is a compact benchtop immune hematology system that report… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072869 | Pointcare Now System | 2008 | 0 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K990172Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…Coulter Corp. · 1999 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K963263Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome…Coulter Corp. · 1997 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 5 of the 11 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K072869 (Pointcare Technologies, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K962988.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GKZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GKZ
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · GKZ
77in 2025
MAUDE reports naming product code GKZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 117 | 37 | 268 |
| 2008 | 6 | 99 | 5 | 925 |
| 2009 | 6 | 147 | 13 | 559 |
| 2010 | 4 | 290 | 27 | 896 |
| 2011 | 3 | 315 | 28 | 2,905 |
| 2012 | 3 | 408 | 7 | 2,959 |
| 2013 | 1 | — | 6 | 3,070 |
| 2014 | 3 | 165 | 0 | 3,112 |
| 2015 | 3 | 273 | 3 | 1,972 |
| 2016 | 3 | 198 | 3 | 3,338 |
| 2017 | 4 | 280 | 3 | 229 |
| 2018 | 3 | 270 | 2 (2) | 497 |
| 2019 | 5 | 210 | 2 | 908 |
| 2020 | 1 | — | 1 | 342 |
| 2021 | 0 | — | 0 | 391 |
| 2022 | 3 | 638 | 4 | 198 |
| 2023 | 4 | 329 | 1 | 155 |
| 2024 | 3 | 157 | 0 | 115 |
| 2025 | 4 | 108 | 1 | 77 |
| 2026 | 4 | 254 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041882 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041882: Flowcare System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041882
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026