510(k) · Cleared

Recalled · Class III · 2015

BD Facscanto System

K040725510(k) TraditionalCleared Sep 10, 2004172-day reviewClass II21 CFR 864.5220Recalls 2

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

Becton Dickinson Immunocytometry Systems · GKZ Counter, Differential Cell

Cleared on Sep 10, 2004 as substantially equivalent to K973483 (Becton Dickinson Immunocytometry Systems, 1998) after a 172-day review. Its family tree reaches back 3 generations to 1994. 4 later devices descend from it. It has been recalled 2 times.

Decided: Sep 10, 2004
Review: 172 days
Class: Class II
Product code: GKZ
Recalls: 2
Predicates: 1

Its longest line of descent runs back 3 generations to K925274 (1994). 4 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK925274 Autocomp (TM) Software and Calibrite (TM) BeadsBecton Dickinson Immunocytometry Systems · 1994
2 generations backK961623 Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp BeadsBecton Dickinson Monoclonal Center · 1996
1 generation backK973483 Facscomp Software and Calibrite Beads for Use in Flow Cytometer…Becton Dickinson Immunocytometry Systems · 1998 · Recalled
This deviceK040725 BD Facscanto SystemBecton Dickinson Immunocytometry Systems · 2004
Descendant · cites it directly · 2 of its ownK141468 BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD…Bd Biosciences · 2015
Descendant · cites it directly · 2 of its ownK062087 BD Facscanto II Flow Cytometer, Model 338960; (5-3), Model 339473…Bd Biosciences · 2006 · Recalled
Descendant · 2 generations on · 1 of its ownK170974 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical…Becton, Dickinson and Company · 2017 · Recalled
Descendant · 3 generations on · 0 of its ownK201814 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5…Becton, Dickinson and Company · 2020 · Recalled

Most influential descendants

Showing 4 of 4 · See all

K141468BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow…Bd Biosciences · 2015 · cites it directly2descendants
K062087BD Facscanto II Flow Cytometer, Model 338960; (5-3), Model 339473; (4-2-2), Model 338962Bd Biosciences · 2006 · cites it directly2descendants
K170974BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD…Becton, Dickinson and Company · 2017 · 2 generations on1descendant
K201814BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations)…Becton, Dickinson and Company · 2020 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K925274	Autocomp (TM) Software and Calibrite (TM) Beads	Becton Dickinson Immunocytometry Systems	1994	—
−2	K961623	Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp Beads	Becton Dickinson Monoclonal Center	1996	—
−1	K973483	Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set	Becton Dickinson Immunocytometry Systems	1998	1
0 (this device)	K040725	BD Facscanto System	Becton Dickinson Immunocytometry Systems	2004	—
+1	K141468	BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto…	Bd Biosciences	2015	—
+1	K062087	BD Facscanto II Flow Cytometer, Model 338960; (5-3), Model 339473; (4-2-2)…	Bd Biosciences	2006	3
+2	K170974	BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical…	Becton, Dickinson and Company	2017	17
+3	K201814	BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical…	Becton, Dickinson and Company	2020	5

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2015	1	0
2017	1	0
2020	1	0

FIG. 1 — Lineage of K040725, 1994–2020Source: 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
*	K973483	Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set Summary page 1 …s and associated software. EACSCalibur 4-color instmument was cleared with FACSComp Software and CahiBRITE Beads by the Center for Devices and Radiological Health, under K973483 on 2/17/98. The BD FACSCanto System with BD FACSDiva software and BD FACSCalibur have similar intended uses, measure the same sam…	Becton Dickinson Immunocytometry Systems	1998	1

Also cleared against K973483: 4 other devices →

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K141468	BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow…	Bd Biosciences	2015	2
K062087	BD Facscanto II Flow Cytometer, Model 338960; (5-3), Model 339473; (4-2-2), Model 338962	Bd Biosciences	2006	2

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 15, 2015	Class III	Z-2090-2015	Labeling Change Control	Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50).
Dec 21, 2007	Not classified	Z-1530-2008	Software design	Values might not update in statistics views after certain functions are performed in a worksheet.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
1 of the 3 ancestors has a recall of any class.
Of its descendants, K141468 (Bd Biosciences, 2015) has gone furthest, with 2 descendants of its own.
4 other devices also cite its predicate K973483.

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?

Immunophenotyping in clinical laboratories, using previously cleared IVD assays for flow cytometry that utilize the lyse wash sample preparation method.

Immunophenotyping of lymphocyte subsets including CD3+CD8 +, CD3+CD4 +, CD3-CD 16+ and/or CD56 +, CD3-CD19 +, and CD3 +.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040725 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040725: BD Facscanto System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040725

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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