510(k) · Cleared
ClearedFacscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp Beads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Monoclonal Center · GKZ Counter, Differential Cell
Cleared on Jun 7, 1996 as substantially equivalent to K925274 (Becton Dickinson Immunocytometry Systems, 1994) after a 42-day review. Its family tree reaches back 1 generation to 1994. 12 later devices descend from it.
- Decided
- Jun 7, 1996
- Review
- 42 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925274 (1994). 12 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK925274 Autocomp (TM) Software and Calibrite (TM) BeadsBecton Dickinson Immunocytometry Systems · 1994
- This deviceK961623 Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp BeadsBecton Dickinson Monoclonal Center · 1996
- Descendant · cites it directly · 11 of its ownK973483 Facscomp Software and Calibrite Beads for Use in Flow Cytometer…Becton Dickinson Immunocytometry Systems · 1998 · Recalled
- Descendant · 2 generations on · 6 of its ownK041074 BD Facscanto with BD Facsanto SoftwareBd Biosciences · 2004 · Recalled
- Descendant · 2 generations on · 4 of its ownK040725 BD Facscanto SystemBecton Dickinson Immunocytometry Systems · 2004 · Recalled
- Descendant · 3 generations on · 3 of its ownK060375 BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models…Bd Biosciences · 2006
- Descendant · 3 generations on · 2 of its ownK141468 BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD…Bd Biosciences · 2015
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K973483Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument SetBecton Dickinson Immunocytometry Systems · 1998 · cites it directly11descendants
- K041074BD Facscanto with BD Facsanto SoftwareBd Biosciences · 2004 · 2 generations on6descendants
- K040725BD Facscanto SystemBecton Dickinson Immunocytometry Systems · 2004 · 2 generations on4descendants
- K060375BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166Bd Biosciences · 2006 · 3 generations on3descendants
- K141468BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow…Bd Biosciences · 2015 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925274 | Autocomp (TM) Software and Calibrite (TM) Beads | Becton Dickinson Immunocytometry Systems | 1994 | — |
| 0 (this device) | 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 |
| +2 | K041074 | BD Facscanto with BD Facsanto Software | Bd Biosciences | 2004 | 1 |
| +2 | K040725 | BD Facscanto System | Becton Dickinson Immunocytometry Systems | 2004 | 2 |
| +3 | K060375 | BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166 | Bd Biosciences | 2006 | — |
| +3 | K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto… | Bd Biosciences | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K925274 | Autocomp (TM) Software and Calibrite (TM) BeadsSummary page 1…Accessory to a Class II Device Predicate Device (21 CER 807.92()(3)) CaliBRITE™ 3 Color and FACSComp™ is substantially equivalent to CaliBRITE™ Beads with AutoCOMPT™ (K 925274), cleared to market in September, 1994. Descrintion of the Device (21 CER 807.926a)(4) Becton Dickinson CaliBRITE 3 Color and F… | 1994 |
What descends from it? (12)
See all 123 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?
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 procedure employs a Becton Dickinson flow cytometer and recommended computer hardware and software.
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/K961623 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961623: Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp Beads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961623
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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