510(k) · Cleared
Recalled · Class III · 2015Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set
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 Feb 17, 1998 as substantially equivalent to K961623 (Becton Dickinson Monoclonal Center, 1996) after a 155-day review. Its family tree reaches back 2 generations to 1994. 11 later devices descend from it. It has been recalled once.
- Decided
- Feb 17, 1998
- Review
- 155 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925274 (1994). 11 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK925274 Autocomp (TM) Software and Calibrite (TM) BeadsBecton Dickinson Immunocytometry Systems · 1994
- 1 generation backK961623 Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp BeadsBecton Dickinson Monoclonal Center · 1996
- This deviceK973483 Facscomp Software and Calibrite Beads for Use in Flow Cytometer…Becton Dickinson Immunocytometry Systems · 1998
- Descendant · cites it directly · 6 of its ownK041074 BD Facscanto with BD Facsanto SoftwareBd Biosciences · 2004 · Recalled
- Descendant · cites it directly · 4 of its ownK040725 BD Facscanto SystemBecton Dickinson Immunocytometry Systems · 2004 · Recalled
- Descendant · 2 generations on · 3 of its ownK060375 BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models…Bd Biosciences · 2006
- Descendant · 2 generations on · 2 of its ownK141468 BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD…Bd Biosciences · 2015
- Descendant · 3 generations on · 2 of its ownK090967 BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 2009 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K041074BD Facscanto with BD Facsanto SoftwareBd Biosciences · 2004 · cites it directly6descendants
- K040725BD Facscanto SystemBecton Dickinson Immunocytometry Systems · 2004 · cites it directly4descendants
- K060375BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166Bd Biosciences · 2006 · 2 generations on3descendants
- K141468BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow…Bd Biosciences · 2015 · 2 generations on2descendants
- K090967BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 2009 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K973483 | Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set | Becton Dickinson Immunocytometry Systems | 1998 | — |
| +1 | K041074 | BD Facscanto with BD Facsanto Software | Bd Biosciences | 2004 | 1 |
| +1 | K040725 | BD Facscanto System | Becton Dickinson Immunocytometry Systems | 2004 | 2 |
| +2 | K060375 | BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166 | Bd Biosciences | 2006 | — |
| +2 | K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto… | Bd Biosciences | 2015 | — |
| +3 | K090967 | BD Multitest 6-Color TBNK Reagent, Model 644611 | Bd Biosciences | 2009 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K961623 | Facscomp Software & Calibrite 3 Color Beads Kit/Calibrite Percp BeadsSummary page 1…aliBRITE™ 4 kit and FACSComp™ software is substantially equivalent to CaliBRITE™ 3 kit (unlabeled, FITC-, PE-, and PerCP-labeled CaliBRITE beads) and FACSCOMP™ software, K961623, cleared to market on June 7, 1996. Description of the Device (21 CFR 807.92(a)(4)) Becton Dickinson FACSComp software and the… | 1996 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041074 | BD Facscanto with BD Facsanto Software | 2004 | 6 |
| K040725 | BD Facscanto System | 2004 | 4 |
| K040026 | BD Facs 7-Color Setup Beads | 2004 | 2 |
| K141932 | Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol… | 2015 | 0 |
| K060423 | Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and Fluorospheres | 2006 | 0 |
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 4 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K041074 (Bd Biosciences, 2004) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K961623.
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?
For the FACS® family of flow cytometers (FACScan, FACSort and FACSCalibur). An accessory device for instrument setup prior to performing reticulocyte ennumeration and immunophenotyping. For adjusting instrument settings: aligning the signal from the bluc and the optional red laser (FL4 Option), setting the photomultiplier tube (PMT) voltages, and monitoring instrument performance over time. For automatically setting the fluorescence compensation of the…
Read the full statement (104 words)
For the FACS® family of flow cytometers (FACScan, FACSort and FACSCalibur).
An accessory device for instrument setup prior to performing reticulocyte ennumeration and immunophenotyping.
For adjusting instrument settings: aligning the signal from the bluc and the optional red laser (FL4 Option), setting the photomultiplier tube (PMT) voltages, and monitoring instrument performance over time.
For automatically setting the fluorescence compensation of the detectors to adjust for spectral overlap of fluorescent signals.
For monitoring the sensitivity of che side scateer (SSC) and fluorescence (FL1, FL2, FL3, and FL4) dctecrors and verifying adequate separation of system noise from forward scatter (FSC) signals.
For in vitro diagnostic use.
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/K973483 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973483: Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973483
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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