510(k) · Cleared
Recalled · Class III · 2015BD Facscanto II Flow Cytometer, Model 338960; (5-3), Model 339473; (4-2-2), Model 338962
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Biosciences · GKZ Counter, Differential Cell
Cleared on Sep 14, 2006 as substantially equivalent to K041074 (Bd Biosciences, 2004) and 1 other predicate after a 52-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 14, 2006
- Review
- 52 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 4 generations to K925274 (1994). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK925274 Autocomp (TM) Software and Calibrite (TM) BeadsBecton Dickinson Immunocytometry Systems · 1994
- 3 generations backK961623 Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp BeadsBecton Dickinson Monoclonal Center · 1996
- 2 generations backK973483 Facscomp Software and Calibrite Beads for Use in Flow Cytometer…Becton Dickinson Immunocytometry Systems · 1998 · Recalled
- 1 generation backK040725 BD Facscanto SystemBecton Dickinson Immunocytometry Systems · 2004 · Recalled
- This deviceK062087 BD Facscanto II Flow Cytometer, Model 338960; (5-3), Model 339473…Bd Biosciences · 2006
- Descendant · cites it directly · 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 · 2 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 2 of 2 · See all- K170974BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD…Becton, Dickinson and Company · 2017 · cites it directly1descendant
- 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 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K925274 | Autocomp (TM) Software and Calibrite (TM) Beads | Becton Dickinson Immunocytometry Systems | 1994 | — |
| −3 | K961623 | Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp Beads | Becton Dickinson Monoclonal Center | 1996 | — |
| −2 | K973483 | Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set | Becton Dickinson Immunocytometry Systems | 1998 | 1 |
| −1 | K040725 | BD Facscanto System | Becton Dickinson Immunocytometry Systems | 2004 | 2 |
| 0 (this device) | K062087 | BD Facscanto II Flow Cytometer, Model 338960; (5-3), Model 339473; (4-2-2)… | Bd Biosciences | 2006 | — |
| +1 | K170974 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical… | Becton, Dickinson and Company | 2017 | 17 |
| +2 | 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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K041074 | BD Facscanto with BD Facsanto SoftwareSummary page 1…e The BD FACSCanto II system is substantially equivalent to the BD FACSCanto system with BD FACSCanto clinical software and BD FACSDiva software (premarket notifications K041074 and K040725). Device Description The BD FACSCanto II system is comprised of a flow cytometer, a fluidics cart, an… | 2004 |
| * | K040725 | BD Facscanto SystemSummary page 1…SCanto II system is substantially equivalent to the BD FACSCanto system with BD FACSCanto clinical software and BD FACSDiva software (premarket notifications K041074 and K040725). Device Description The BD FACSCanto II system is comprised of a flow cytometer, a fluidics cart, and a computer… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170974 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD… | 2017 | 1 |
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. |
| Apr 5, 2007 | Not classified | Z-1525-2008 | Software design | When data file containing one or no fluoresence parameters is exported, the software will automatically apply compensation to this file and all subsequently exported files. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K170974 (Becton, Dickinson and Company, 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K041074.
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?
Immunophenotyping in clinical laboratories, using previously cleared in vitro diagnostic assays for flow cytometry.
Identification and enumeration of lymphocyte subsets in human cells in suspension.
For in vitro diagnostic use.
For use with or without the BD FACS Sample Prep Assistant II.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062087 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062087: BD Facscanto II Flow Cytometer, Model 338960; (5-3), Model 339473; (4-2-2), Model 338962.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062087
Report an extraction error
Are you the manufacturer?
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