510(k) · Cleared
Recalled · 2011Cell-Dyn 3500 System with Immature Reticulocyte Fraction (Irf), Cell-Dyn 3700 System with Immature Reticulocyte Fraction
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 Jul 9, 1999 as substantially equivalent to K971152 (Abbott Laboratories, 1997) after a 60-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it. It has been recalled 9 times.
- Decided
- Jul 9, 1999
- Review
- 60 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971152 (1997). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK971152 Abbott Cell-Dyn 4000 Immature Reticulocyte Fraction (Irf)Abbott Laboratories · 1997 · Recalled
- This deviceK991605 Cell-Dyn 3500 System with Immature Reticulocyte Fraction (Irf)…Abbott Laboratories · 1999
- Descendant · cites it directly · 1 of its ownK110381 Cell-Dyn Emerald 22 SystemAbbott Laboratories · 2011
- Descendant · 2 generations on · 0 of its ownK190294 CELL-DYN Emerald 22 AL SystemAbbott Laboratories · 2019
- Descendant · cites it directly · 0 of its ownK112755 Abacus 5Diatron U.S., Inc. · 2012 · 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 | K971152 | Abbott Cell-Dyn 4000 Immature Reticulocyte Fraction (Irf) | Abbott Laboratories | 1997 | 1 |
| 0 (this device) | K991605 | Cell-Dyn 3500 System with Immature Reticulocyte Fraction (Irf), Cell-Dyn 3700… | Abbott Laboratories | 1999 | — |
| +1 | K110381 | Cell-Dyn Emerald 22 System | Abbott Laboratories | 2011 | — |
| +2 | K190294 | CELL-DYN Emerald 22 AL System | Abbott Laboratories | 2019 | — |
| +1 | K112755 | Abacus 5 | Diatron U.S., Inc. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 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? (1)
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 |
|---|---|---|---|
| * | K971152 | Abbott Cell-Dyn 4000 Immature Reticulocyte Fraction (Irf)Summary page 1…00 System with Immature Reticulocyte Fraction (IRF) Automated Hematology Analyzers Automated Differential Cell Counter (21 CFR 864.5220) CELL-DYN 4000 System, 510(k) #971152/S1 26 CELL-DYN® 3500 and the CELL-DYN® 3700 System 16. 510(k) Summary (cont’d) 510(k) Notification CELL-DYN 3… | 1997 |
What descends from it? (3)
2 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 |
|---|---|---|---|---|
| Mar 15, 2011 | Not classified | Z-2020-2011 | Pending | The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results. |
| Mar 15, 2011 | Not classified | Z-2015-2011 | Pending | The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results. |
| Mar 15, 2011 | Not classified | Z-2016-2011 | Pending | The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results. |
| Mar 15, 2011 | Not classified | Z-2014-2011 | Pending | The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results. |
| Apr 16, 2010 | Not classified | Z-2351-2010 | Nonconforming Material/Component | Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks. |
| Mar 27, 2009 | Not classified | Z-1701-2011 | Component design/selection | FIRE HAZARD-- Some power supply modules may have incorrect fuses installed, which may result in fires and smoking. |
| Mar 27, 2009 | Not classified | Z-1703-2011 | Component design/selection | FIRE HAZARD-- Some power supply modules may have incorrect fuses installed, which may result in fires and smoking. |
| May 11, 2007 | Not classified | Z-1199-2007 | Other | The product failed electrostatic discharge testing, which could result in product failure. |
| May 11, 2007 | Not classified | Z-1200-2007 | Other | The product failed electrostatic discharge testing, which could result in product failure. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K110381 (Abbott Laboratories, 2011) has gone furthest, with 1 descendant 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 3500 and the CELL-DYN 3700 Systems are automated, multi-parameter hematology analyzers intended to classify the following formed elements of EDTA anticoagulated blood: WBC -- White Blood Cell or Leukocyte Count NEU -- Neutrophil Absolute Count %N -- Neutrophil Percent LYM -- Lymphocyte Absolute Count %L -- Lymphocyte Percent MONO -- Monocyte Absolute Count %M -- Monocyte Percent EOS -- Eosinophil Absolute Count %E -- Eosinophil Percent BASO…
Read the full statement (161 words)
The CELL-DYN 3500 and the CELL-DYN 3700 Systems are automated, multi-parameter hematology analyzers intended to classify the following formed elements of EDTA anticoagulated blood:
WBC -- White Blood Cell or Leukocyte Count
NEU -- Neutrophil Absolute Count
%N -- Neutrophil Percent
LYM -- Lymphocyte Absolute Count
%L -- Lymphocyte Percent
MONO -- Monocyte Absolute Count
%M -- Monocyte Percent
EOS -- Eosinophil Absolute Count
%E -- Eosinophil Percent
BASO -- Basophil Absolute Count
%B -- Basophil Percent
PLT -- Platelet Count
MPYV -- Mean Platelet Volume
RBC -- Red Blood Cell or Erythrocyte Count
HCT - Hematocrit
MCYV -- Mean Corpuscular Volume
RDW -- Red Cell Distribution Width
HGB -- Hemoglobin Concentration
MCH -- Mean Corpuscular Hemoglobin
MCHC -- Mean Corpuscular Hemoglobin Concentration
RETC -- Reticulocyte Concentration
% RETC -- Reticulocyte Concentration
IRF -- Immature Reticulocyte Fraction
*PDW -- Platelet Distribution Width
*PCT -- Plateletcrit
* These parameters are provided for laboratory use only and are not reportable in the US.
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/K991605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991605: Cell-Dyn 3500 System with Immature Reticulocyte Fraction (Irf), Cell-Dyn 3700 System with Immature Reticulocyte Fraction.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991605
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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