510(k) · Cleared

Cleared

Cell-Dyn 3200 System with Absolute and Percent Reticulocyte

K012934510(k) SpecialCleared Sep 28, 200128-day reviewClass II21 CFR 864.5220

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Abbott Laboratories · GKZ Counter, Differential Cell

Cleared on Sep 28, 2001 as substantially equivalent to K961439 (Abbott Diagnostics, 1996) after a 28-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it.

Decided: Sep 28, 2001
Review: 28 days
Class: Class II
Product code: GKZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K872166 (1987). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK872166 Facscan Flow Cytometer - Reticcount Reti. Enu. KitBd Becton Dickinson Vacutainer Systems Preanalytic · 1987
1 generation backK961439 Abbott Cell-Dyn 4000 SystemAbbott Diagnostics · 1996 · Recalled
This deviceK012934 Cell-Dyn 3200 System with Absolute and Percent ReticulocyteAbbott Laboratories · 2001
Descendant · cites it directly · 0 of its ownK061667 Cell-Dyn Ruby SystemAbbott Laboratories · 2006 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K061667Cell-Dyn Ruby SystemAbbott Laboratories · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K872166	Facscan Flow Cytometer - Reticcount Reti. Enu. Kit	Bd Becton Dickinson Vacutainer Systems Preanalytic	1987	—
−1	K961439	Abbott Cell-Dyn 4000 System	Abbott Diagnostics	1996	7
0 (this device)	K012934	Cell-Dyn 3200 System with Absolute and Percent Reticulocyte	Abbott Laboratories	2001	—
+1	K061667	Cell-Dyn Ruby System	Abbott Laboratories	2006	12

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
2006	1	0

FIG. 1 — Lineage of K012934, 1987–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K961439	Abbott Cell-Dyn 4000 System Summary page 1 …ulocyte Common Name: Automated Hematology Analyzer Classification Name: Automated Differential Cell Counter (21 CRF 864.5220) Predicate Device: CELL-DYN 4000 System, K961439/S1 Intended Use: The CELL-DYN 3200 System with Absolute and Percent Reticulocyte count is a multiparameter, automated hematolog…	Abbott Diagnostics	1996	7

Also cleared against K961439: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K061667	Cell-Dyn Ruby System	Abbott Laboratories	2006	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
2 of the 3 ancestors have a recall of any class.
Of its descendants, K061667 (Abbott Laboratories, 2006) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K961439.

How does its category compare?

All GKZ devices

GKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GKZ

4in 2025

2007high 6 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GKZ

108in 2025

2007high 638 (2022) · low 99 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GKZ

1in 2025

2007high 37 (2007) · low 0 (2014)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · GKZ

77in 2025

2007high 3,338 (2016) · low 77 (2025)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 3200% System with Absolute and Perceat Reticulocyte is an automated, multiparameter hematology analyzer designed to classify the following formed elements of EDTA-anticoagulated blood: White blood Cell Parameters: WBC — White Blood Cell or Leukocyte Count NEU — Neutrophil Absolute Count %N — Neutrophil Percent LYM — Lymphocyte Absolute Count %L — Lymphocyte Percent MONQ — Monocyte Absolute Count %M — Monocyte Percent EOS - Eosinophil…

Read the full statement (176 words)

The CELL-DYN 3200% System with Absolute and Perceat Reticulocyte is an automated, multiparameter hematology analyzer designed to classify the following formed elements of EDTA-anticoagulated blood:

White blood Cell Parameters:

WBC — White Blood Cell or Leukocyte Count

NEU — Neutrophil Absolute Count

%N — Neutrophil Percent

LYM — Lymphocyte Absolute Count

%L — Lymphocyte Percent

MONQ — Monocyte Absolute Count

%M — Monocyte Percent

EOS - Eosinophil Absolute Count

%E -- Eosinophil Percent

BASO -- Basophil Absolute Count

%B -- Basophil Percent

Red Blood Cell Parameters:

RBC -- Red Blood Cell or Erythrocyte Count

HCT -- Hematocrit

MCY -- Mean Cell Volume

RDW -- Red Cell Distribution Width

Hemoglobin Parameters:

HGB - Hemoglobin Concentration

MCH -- Mean Cell Hemoglobin

MCHC - Mean Cell Hemoglobin Concentration

Platelet Parameters:

PLT - Platelet Count

MPV -- Mean Platelet Volume

*PDW -- Platelet Distribution Width

*PCT -- Plateletcrit

Reticulocyte Parameters:

RETIC ABS -- Reticulocyte Absolute

RETIC% - Reticulocyte Percent of RBC Count

* Clinical significance has not been established for these parameters. Therefore, they are not reportable in the U.S.

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/K012934 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012934: Cell-Dyn 3200 System with Absolute and Percent Reticulocyte.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012934

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026