510(k) · Cleared
Recalled · 2009Abbott Cell-Dyn 4000 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Diagnostics · GKZ Counter, Differential Cell
Cleared on Oct 18, 1996 as substantially equivalent to K951496 (Abbott Laboratories, 1995) and 1 other predicate after a 186-day review. Its family tree reaches back 1 generation to 1987. 7 later devices descend from it. It has been recalled 7 times.
- Decided
- Oct 18, 1996
- Review
- 186 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 1 generation to K872166 (1987). 2 ancestors in all. 7 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK872166 Facscan Flow Cytometer - Reticcount Reti. Enu. KitBd Becton Dickinson Vacutainer Systems Preanalytic · 1987
- This deviceK961439 Abbott Cell-Dyn 4000 SystemAbbott Diagnostics · 1996
- Descendant · cites it directly · 2 of its ownK022200 Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics · 2002 · Recalled
- Descendant · cites it directly · 1 of its ownK050719 Abx Pentra DX 120: Option SPS EvolutionHoriba Abx · 2005 · Recalled
- Descendant · cites it directly · 1 of its ownK024002 Pentra 80Abx Diagnostics · 2003 · Recalled
- Descendant · cites it directly · 1 of its ownK012934 Cell-Dyn 3200 System with Absolute and Percent ReticulocyteAbbott Laboratories · 2001
- Descendant · 2 generations on · 0 of its ownK151133 Pentra XLRHoriba Abx Sas · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K022200Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120Abx Diagnostics · 2002 · cites it directly2descendants
- K050719Abx Pentra DX 120: Option SPS EvolutionHoriba Abx · 2005 · cites it directly1descendant
- K024002Pentra 80Abx Diagnostics · 2003 · cites it directly1descendant
- K012934Cell-Dyn 3200 System with Absolute and Percent ReticulocyteAbbott Laboratories · 2001 · cites it directly1descendant
- K151133Pentra XLRHoriba Abx Sas · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872166 | Facscan Flow Cytometer - Reticcount Reti. Enu. Kit | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987 | — |
| 0 (this device) | K961439 | Abbott Cell-Dyn 4000 System | Abbott Diagnostics | 1996 | — |
| +1 | K022200 | Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120 | Abx Diagnostics | 2002 | 2 |
| +1 | K050719 | Abx Pentra DX 120: Option SPS Evolution | Horiba Abx | 2005 | 1 |
| +1 | K024002 | Pentra 80 | Abx Diagnostics | 2003 | 2 |
| +1 | K012934 | Cell-Dyn 3200 System with Absolute and Percent Reticulocyte | Abbott Laboratories | 2001 | — |
| +2 | K151133 | Pentra XLR | Horiba Abx Sas | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2015 | 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.
Planning a device in GKZ? 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? (2)
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 |
|---|---|---|---|
| * | K951496 | Cell-Dyn 3500 Multi-Parameter Automated Hematology AnalyzerSummary page 1…ent determination. Substantial equivalence is demonstrated between the CELL-DYN® 4000 System and the Abbott CELL-DYN 3500 Multi-Parameter Automated Hematology Analyzer, #K951496/S001 for the hemagram and white cell (WBC) differential parameters. Substantial equivalence is also demonstrated between the CELL… | 1995 |
| * | K872166 | Facscan Flow Cytometer - Reticcount Reti. Enu. KitSummary page 1…ntial equivalence is also demonstrated between the CELL-DYN® 4000 System and the Becton Dickinson FACScan™ Flow Cytometer ReticCOUNT™ Reticulocyte Enumeration Software, #K872166/A for reticulocytes. For enumeration of nucleated red blood cells (NRBCs) equivalence is demonstrated by comparison to the manua… | 1987 |
What descends from it? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 29, 2009 | Not classified | Z-1623-2011 | Other | A component used in assembly is out of specification, resulting in failure to retract, eject specimens, exposure below the safety zone, piercing of specimen tubes, or error message to display. |
| Dec 19, 2007 | Not classified | Z-1103-2008 | Material/Component Contamination | Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination. |
| Dec 22, 2006 | Not classified | Z-0565-2007 | Other | Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems. |
| Apr 17, 2006 | Not classified | Z-0708-2007 | Other | High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results unacceptable -out-of-range. |
| May 12, 2004 | Not classified | Z-0639-2007 | Other | Incorrect Test Results-test results may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range). |
| Feb 24, 2004 | Not classified | Z-0640-2007 | Other | Incorrect Test Results-product may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range). |
| Oct 16, 2002 | Not classified | Z-0648-03 | Other | Product elicits fluorescent signal interference due to contamination. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K022200 (Abx Diagnostics, 2002) has gone furthest, with 2 descendants of its own.
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 CELL-DYN® 4000 System is a fully automated hematology analyzer intended for in-vitro diagnostic use in the clinical hematology laboratory of a hospital, medical clinic, or reference laboratory.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961439 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961439: Abbott Cell-Dyn 4000 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961439
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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