510(k) · Cleared
Recalled · 2007Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer (Modification)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · GKZ Counter, Differential Cell
Cleared on Oct 8, 1996 as substantially equivalent to K823355 (Coulter Electronics, Inc., 1982) and 1 other predicate after a 313-day review. Its family tree reaches back 1 generation to 1982. 3 later devices descend from it. It has been recalled once.
- Decided
- Oct 8, 1996
- Review
- 313 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K823355 (1982). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK823355 Coulter-Counter #S Plus IV & Lyse S +DCoulter Electronics, Inc. · 1982
- This deviceK955715 Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer…Abbott Laboratories · 1996
- Descendant · cites it directly · 2 of its ownK972354 Abbott Cell-Dyn 3200 SystemAbbott Laboratories · 1997 · Recalled
- Descendant · 2 generations on · 1 of its ownK980614 Abbott Cell-Dyn 3000 Series Hematology SystemsAbbott Laboratories · 1998 · Recalled
- Descendant · 2 generations on · 0 of its ownK061667 Cell-Dyn Ruby SystemAbbott Laboratories · 2006 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K823355 | Coulter-Counter #S Plus IV & Lyse S +D | Coulter Electronics, Inc. | 1982 | — |
| 0 (this device) | K955715 | Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer (Modification) | Abbott Laboratories | 1996 | — |
| +1 | K972354 | Abbott Cell-Dyn 3200 System | Abbott Laboratories | 1997 | 6 |
| +2 | K980614 | Abbott Cell-Dyn 3000 Series Hematology Systems | Abbott Laboratories | 1998 | 5 |
| +2 | K061667 | Cell-Dyn Ruby System | Abbott Laboratories | 2006 | 12 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2006 | 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? (5)
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 |
|---|---|---|---|
| * | K823355 | Coulter-Counter #S Plus IV & Lyse S +DSummary page 1…1976), Coulter Hemoglobinometer (marketed prior to May 1976), the Coulter Model S (marketed prior to May 1976), and the Coulter Model S Plus IV, Premarket Notification #K823355. Intended Use The Cell-Dyn 3500 is a multi-parameter, hematology analyzer designed for In-Vitro diagnostic use in clinical labo… | 1982 |
| * | K913305 | Cell-Dyn 3000A Multi-Parameter Auto Hema AnalzyerSummary page 2…nstrument are intended to enhance the safety and effectiveness of the Cell-Dyn 3500 and demonstrate substantial equivalence to the Coulter S Plus IV and Cell-Dyn 3500, #K913305/A. 3/21/96 2 0179 Cell-Dyn® 3500 Systemn 510(k) Summary Conclusion In conclusion, the Cell-Dyn 3500 update show… | 1991 |
| * | — | Coulter® ZBI Named without a submission number | |
| * | — | Coulter Hemoglobinometer Named without a submission number | |
| * | — | Coulter Model S Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972354 | Abbott Cell-Dyn 3200 System | 1997 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 11, 2007 | Not classified | Z-1199-2007 | Other | The product failed electrostatic discharge testing, which could result in product failure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 3500 is a multi-parameter, hematology analyzer designed for In-Vitro diagnostic use in clinical laboratories.
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/K955715 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955715: Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955715
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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