510(k) · Cleared
ClearedCyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coulter Immunology · GKZ Counter, Differential Cell
Cleared on Feb 5, 1993 after a 242-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 of the 19 devices in its family, counting itself, have a Class I recall. 18 later devices descend from it.
- Decided
- Feb 5, 1993
- Review
- 242 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 3 citing it directly. 4 of the 19 devices in this family, counting this one, have a Class I recall.
- This deviceK922745 Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1Coulter Immunology · 1993
- Descendant · cites it directly · 15 of its ownK963263 Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat…Coulter Corp. · 1997 · Recalled (Class I)
- Descendant · 2 generations on · 14 of its ownK990172 Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat…Coulter Corp. · 1999 · Recalled (Class I)
- Descendant · 3 generations on · 6 of its ownK030828 Tetracxp System (Software and System Guide)Beckman Coulter, Inc. · 2003 · Recalled (Class I)
- Descendant · 4 generations on · 3 of its ownK130373 Navios Flow Cytometer SystemBeckman Coulter, Inc. · 2013
- Descendant · 5 generations on · 2 of its ownK162897 Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer…Beckman Coulter · 2017
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K963263 Tetraone System for Epics XL Flow Cytometry…cites it directly · 1997
- K990172 Tetraone System for Epics XL Flow Cytometry…2 generations on · 1999
- K030828 Tetracxp System (Software and System Guide)3 generations on · 2003
- K071681 Cytomics FC 500 MPL Flow Cytometer, Model # 6265544 generations on · 2007
Most influential descendants
Showing 5 of 18 · See all- K963263Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome…Coulter Corp. · 1997 · cites it directly15descendants
- K990172Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…Coulter Corp. · 1999 · 2 generations on14descendants
- K030828Tetracxp System (Software and System Guide)Beckman Coulter, Inc. · 2003 · 3 generations on6descendants
- K130373Navios Flow Cytometer SystemBeckman Coulter, Inc. · 2013 · 4 generations on3descendants
- K162897Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser…Beckman Coulter · 2017 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922745 | Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1 | Coulter Immunology | 1993 | — |
| +1 | K963263 | Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome… | Coulter Corp. | 1997 | Class I |
| +2 | K990172 | Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome… | Coulter Corp. | 1999 | Class I |
| +3 | K030828 | Tetracxp System (Software and System Guide) | Beckman Coulter, Inc. | 2003 | Class I |
| +4 | K130373 | Navios Flow Cytometer System | Beckman Coulter, Inc. | 2013 | — |
| +5 | K162897 | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2… | Beckman Coulter | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 1 |
| 1999 | 1 | 1 |
| 2003 | 2 | 1 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 1 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 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.
4 devices in this family have a Class I recall. 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? (18)
See all 183 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K963263Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome…Coulter Corp. · 1997 · Cites it directly · ◆ in the 1997 descendants bar of FIG. 11 Class I recall
- K990172Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…Coulter Corp. · 1999 · 2 generations on · ◆ in the 1999 descendants bar of FIG. 11 Class I recall
- K030828Tetracxp System (Software and System Guide)Beckman Coulter, Inc. · 2003 · 3 generations on · ◆ in the 2003 descendants bar of FIG. 11 Class I recall
- K071681Cytomics FC 500 MPL Flow Cytometer, Model # 626554Beckman Coulter, Inc. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K963263 (Coulter Corp., 1997) has gone furthest, with 15 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/K922745 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922745: Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922745
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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