510(k) · Cleared
Recalled · Class III · 2015BD Facscanto with BD Facsanto Software
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 17, 2004 as substantially equivalent to K973483 (Becton Dickinson Immunocytometry Systems, 1998) after a 144-day review. Its family tree reaches back 3 generations to 1994. 6 later devices descend from it. It has been recalled once.
- Decided
- Sep 17, 2004
- Review
- 144 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K925274 (1994). 6 later devices descend from it, 3 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 deviceK041074 BD Facscanto with BD Facsanto SoftwareBd Biosciences · 2004
- Descendant · cites it directly · 3 of its ownK060375 BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models…Bd Biosciences · 2006
- 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 · 2 generations on · 2 of its ownK090967 BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 2009 · Recalled
- 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K060375BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166Bd Biosciences · 2006 · cites it directly3descendants
- K141468BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow…Bd Biosciences · 2015 · cites it directly2descendants
- K090967BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 2009 · 2 generations on2descendants
- 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
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) | K041074 | BD Facscanto with BD Facsanto Software | Bd Biosciences | 2004 | — |
| +1 | K060375 | BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166 | Bd Biosciences | 2006 | — |
| +1 | K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto… | Bd Biosciences | 2015 | — |
| +2 | K090967 | BD Multitest 6-Color TBNK Reagent, Model 644611 | Bd Biosciences | 2009 | 3 |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K973483 | Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument SetSummary page 3…tiset software. The BD FACSCalibuar 4-color instrument was cleared with FACSComnp Software and CaliBRITE Beads by the Center for Devices and Radiological Health, under K973483 on 2/17/98. The BD EACSCanto with BD FACSCanto software and BD FACSCalibur have similar intended uses, measure the same sample t… | 1998 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060375 | BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166 | 2006 | 3 |
| K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow… | 2015 | 2 |
| K062087 | BD Facscanto II Flow Cytometer, Model 338960; (5-3), Model 339473; (4-2-2), Model 338962 | 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). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 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, K060375 (Bd Biosciences, 2006) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K973483.
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 IVD assays for flow cytometry that utilize the lyse no-wash sample preparation method.
Immunophenotyping of lymphocyte subsets including CD3+CD8+, CD3+CD4+, CD3-CD16+ and/or CD56+, CD3-CD19+, and CD3+.
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/K041074 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041074: BD Facscanto with BD Facsanto Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041074
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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