510(k) · Cleared
ClearedAutocomp (TM) Software and Calibrite (TM) 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 30, 1994 after a 711-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 13 later devices descend from it.
- Decided
- Sep 30, 1994
- Review
- 711 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 2 citing it directly.
- This deviceK925274 Autocomp (TM) Software and Calibrite (TM) BeadsBecton Dickinson Immunocytometry Systems · 1994
- Descendant · cites it directly · 12 of its ownK961623 Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp BeadsBecton Dickinson Monoclonal Center · 1996
- Descendant · 2 generations on · 11 of its ownK973483 Facscomp Software and Calibrite Beads for Use in Flow Cytometer…Becton Dickinson Immunocytometry Systems · 1998 · Recalled
- Descendant · 3 generations on · 6 of its ownK041074 BD Facscanto with BD Facsanto SoftwareBd Biosciences · 2004 · Recalled
- Descendant · 3 generations on · 4 of its ownK040725 BD Facscanto SystemBecton Dickinson Immunocytometry Systems · 2004 · Recalled
- Descendant · 4 generations on · 3 of its ownK060375 BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models…Bd Biosciences · 2006
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K961623Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp BeadsBecton Dickinson Monoclonal Center · 1996 · cites it directly12descendants
- K973483Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument SetBecton Dickinson Immunocytometry Systems · 1998 · 2 generations on11descendants
- K041074BD Facscanto with BD Facsanto SoftwareBd Biosciences · 2004 · 3 generations on6descendants
- K040725BD Facscanto SystemBecton Dickinson Immunocytometry Systems · 2004 · 3 generations on4descendants
- K060375BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166Bd Biosciences · 2006 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925274 | Autocomp (TM) Software and Calibrite (TM) Beads | Becton Dickinson Immunocytometry Systems | 1994 | — |
| +1 | 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 |
| +3 | K041074 | BD Facscanto with BD Facsanto Software | Bd Biosciences | 2004 | 1 |
| +3 | K040725 | BD Facscanto System | Becton Dickinson Immunocytometry Systems | 2004 | 2 |
| +4 | K060375 | BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166 | Bd Biosciences | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 3 | 0 |
| 2009 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K961623 (Becton Dickinson Monoclonal Center, 1996) has gone furthest, with 12 descendants 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 | — |
https://510kreport.com/device/K925274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925274: Autocomp (TM) Software and Calibrite (TM) Beads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925274
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026