510(k) · Cleared
Recalled · Class II · 2025BD Facs 7-Color Setup Beads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Immunocytometry Systems · GKZ Counter, Differential Cell
Cleared on Sep 10, 2004 as substantially equivalent to K000897 (Bd Biosciences, 2000) and 3 other predicates after a 247-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 10, 2004
- Review
- 247 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 3 generations to K925274 (1994). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- 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 deviceK040026 BD Facs 7-Color Setup BeadsBecton Dickinson Immunocytometry Systems · 2004
- 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 |
|---|---|---|---|---|---|
| −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) | K040026 | BD Facs 7-Color Setup Beads | Becton Dickinson Immunocytometry Systems | 2004 | — |
| +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 |
|---|---|---|
| 2000 | 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? (4)
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 |
|---|---|---|---|
| * | K000897 | Calibrite Percp-CY5.5 Beads and Facscomp SoftwareSummary page 1…l beads) Substantially Equivalent*/Predicate Device (21 CFR 807.92(a)(3)) BD FACSTM 7-color setup beads are substantially equivalent to CaliBRITETM beads cleared in K000897 (05/05/2000), K973483 (02/17/1998), K961623 (06/07/1996), and K925274 (09/30/1994). Device Description (21 CFR 807.92(a)(4))… | 2000 |
| * | K973483 | Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument SetSummary page 1…y Equivalent*/Predicate Device (21 CFR 807.92(a)(3)) BD FACSTM 7-color setup beads are substantially equivalent to CaliBRITETM beads cleared in K000897 (05/05/2000), K973483 (02/17/1998), K961623 (06/07/1996), and K925274 (09/30/1994). Device Description (21 CFR 807.92(a)(4)) BD FACS 7-color setup… | 1998 |
| * | K961623 | Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp BeadsSummary page 1…e Device (21 CFR 807.92(a)(3)) BD FACSTM 7-color setup beads are substantially equivalent to CaliBRITETM beads cleared in K000897 (05/05/2000), K973483 (02/17/1998), K961623 (06/07/1996), and K925274 (09/30/1994). Device Description (21 CFR 807.92(a)(4)) BD FACS 7-color setup beads are intended fo… | 1996 |
| * | K925274 | Autocomp (TM) Software and Calibrite (TM) BeadsSummary page 1…(3)) BD FACSTM 7-color setup beads are substantially equivalent to CaliBRITETM beads cleared in K000897 (05/05/2000), K973483 (02/17/1998), K961623 (06/07/1996), and K925274 (09/30/1994). Device Description (21 CFR 807.92(a)(4)) BD FACS 7-color setup beads are intended for use on the BD FACSCanto… | 1994 |
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 3, 2025 | Class II | Z-2079-2025 | Process control | Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples. |
| Jun 3, 2025 | Class II | Z-2078-2025 | Process control | Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples. |
| Jun 29, 2012 | Class II | Z-2397-2012 | Employee error | Incorrect version of the CD was included with BD FACS 7 Color Setup Beads. |
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 4 ancestors has a recall of any class.
- Of its descendants, K170974 (Becton, Dickinson and Company, 2017) 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 beads are for use on a BD FACSCantoTM flow cytometer equipped with BD FACSCanto software.
The beads are used to adjust detector voltages, to set fluorescence compensation and to monitor daily instrument performance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040026: BD Facs 7-Color Setup Beads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040026
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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