510(k) · Cleared
Recalled · 2011Pointcare Now 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 Jan 14, 2008 as substantially equivalent to K041882 (Pointcare Technologies, Inc., 2004) and 3 other predicates after a 97-day review. Its family tree reaches back 4 generations to 1993. 2 of the 22 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Jan 14, 2008
- Review
- 97 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K922745 (1993). 21 ancestors in all, the oldest K885093 (1988). No later device cites it as a predicate yet. 2 of the 22 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK922745 Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1Coulter Immunology · 1993
- 3 generations backK963263 Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat…Coulter Corp. · 1997 · Recalled (Class I)
- 2 generations backK990172 Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat…Coulter Corp. · 1999 · Recalled (Class I)
- 1 generation backK041882 Flowcare SystemPointcare Technologies, Inc. · 2004
- This deviceK072869 Pointcare Now SystemPointcare Technologies, Inc. · 2008
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922745 | Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1 | Coulter Immunology | 1993 | — |
| −3 | K963263 | Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome… | Coulter Corp. | 1997 | Class I |
| −2 | K990172 | Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome… | Coulter Corp. | 1999 | Class I |
| −1 | K041882 | Flowcare System | Pointcare Technologies, Inc. | 2004 | — |
| 0 (this device) | K072869 | Pointcare Now System | Pointcare Technologies, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K041882 | Flowcare SystemSummary page 1…ed Differential Cell Counter 3. PREDICATE DEVICES * Flow~are/AuRICA Flow Cytometer PointCare Technologies, Inc. K041882 * Excell 22 Hematology Analyzer MWI, Inc. K991 539 * Sysmex XE-21… | 2004 |
| * | K991539 | Excell 22Summary page 1…tometer PointCare Technologies, Inc. K041882 * Excell 22 Hematology Analyzer MWI, Inc. K991 539 * Sysmex XE-21100 Hematology Analyzer Sysmex Corp. K992875 * Flow… | 1999 |
| * | K992875 | Sysmex XE-2100, Automatated Hematology AnalyzerSummary page 1…atology Analyzer MWI, Inc. K991 539 * Sysmex XE-21100 Hematology Analyzer Sysmex Corp. K992875 * FlowCare PLGTM System for EPICS XL Flow Cytometry Systems Beckman Coulter, Inc.… | 1999 |
| * | K043215 | Flowcare PLG CD4 ReagentSummary page 1…Sysmex Corp. K992875 * FlowCare PLGTM System for EPICS XL Flow Cytometry Systems Beckman Coulter, Inc. K043215 PointCare Technologies, Inc. 510(k) October 3, 2007 CONFIDENTIAL PointCare NOW System -5 10(k) Summary… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 2, 2011 | Not classified | Z-1193-2012 | Storage | Stability not assured at labeled temperature 2-42C |
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 · 2 generations back · ◆ 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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 8 of the 21 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 PointCare NOW System is an automated hematology system intended for in vitro diagnostic use in performing the direct enumeration of major white blood cell populations, certain T-lymphocyte subsets, and hemoglobin concentration from human whole blood. Whole blood samples can be analyzed with the PointCare NOW System for the following parameters: * White Blood Cell Count * Lymphocyte Count * Lymphocyte Percentage (of White Blood Cells) * CD4…
Read the full statement (129 words)
The PointCare NOW System is an automated hematology system intended for in vitro diagnostic use in performing the direct enumeration of major white blood cell populations, certain T-lymphocyte subsets, and hemoglobin concentration from human whole blood.
Whole blood samples can be analyzed with the PointCare NOW System for the following parameters:
* White Blood Cell Count
* Lymphocyte Count
* Lymphocyte Percentage (of White Blood Cells)
* CD4 T-Lymphocyte Count
* CD4 Percentage (of total Lymphocytes)
* Monocyte Count
* Monocyte Percentage (of White Blood Cells)
* Neutrophil Count
* Neutrophil Percentage (of White Blood Cells)
* Eosinophil Count
* Eosinophil Percentage (of White Blood Cells)
* Hemoglobin Concentration
The PointCare NOW System and its methods for 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/K072869 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072869: Pointcare Now System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072869
Report an extraction error
Are you the manufacturer?
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