510(k) · Cleared
ClearedCytomics FC 500 Series (MPL or MCL) Flow Cytometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter · GKZ Counter, Differential Cell
Cleared on Sep 6, 2019 as substantially equivalent to K071681 (Beckman Coulter, Inc., 2007) and 1 other predicate after a 326-day review. Its family tree reaches back 5 generations to 1993. 4 of the 9 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 6, 2019
- Review
- 326 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K922745 (1993). 8 ancestors in all. No later device cites it as a predicate yet. 4 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK922745 Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1Coulter Immunology · 1993
- 4 generations backK963263 Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat…Coulter Corp. · 1997 · Recalled (Class I)
- 3 generations backK990172 Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat…Coulter Corp. · 1999 · Recalled (Class I)
- 2 generations backK030828 Tetracxp System (Software and System Guide)Beckman Coulter, Inc. · 2003 · Recalled (Class I)
- 1 generation backK071681 Cytomics FC 500 MPL Flow Cytometer, Model # 626554Beckman Coulter, Inc. · 2007 · Recalled (Class I)
- This deviceK182886 Cytomics FC 500 Series (MPL or MCL) Flow CytometerBeckman Coulter · 2019
Class I recalls in this family
- K071681 Cytomics FC 500 MPL Flow Cytometer, Model # 626554direct predicate · 2007
- K030828 Tetracxp System (Software and System Guide)direct predicate · 2003
- K990172 Tetraone System for Epics XL Flow Cytometry…2 generations back · 1999
- K963263 Tetraone System for Epics XL Flow Cytometry…3 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922745 | Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1 | Coulter Immunology | 1993 | — |
| −4 | K963263 | Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome… | Coulter Corp. | 1997 | Class I |
| −3 | K990172 | Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome… | Coulter Corp. | 1999 | Class I |
| −2 | K030828 | Tetracxp System (Software and System Guide) | Beckman Coulter, Inc. | 2003 | Class I |
| −1 | K071681 | Cytomics FC 500 MPL Flow Cytometer, Model # 626554 | Beckman Coulter, Inc. | 2007 | Class I |
| 0 (this device) | K182886 | Cytomics FC 500 Series (MPL or MCL) Flow Cytometer | Beckman Coulter | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1998 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K071681 | Cytomics FC 500 MPL Flow Cytometer, Model # 626554Summary page 5…Classification 21 CFR Number Code FC 500 MPL K071681 Oct 4, 2007 Class II 864.5220 GKZ FC 500 MCL K030828 May 21, 2003… | 2007 |
| * | K030828 | Tetracxp System (Software and System Guide)Summary page 5…Code FC 500 MPL K071681 Oct 4, 2007 Class II 864.5220 GKZ FC 500 MCL K030828 May 21, 2003 Class II 864.5220 GKZ FC 500 Flow Cytometer The FC 500 Flow Cytometer has two cleare… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K071681Cytomics FC 500 MPL Flow Cytometer, Model # 626554Beckman Coulter, Inc. · 2007 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K030828Tetracxp System (Software and System Guide)Beckman Coulter, Inc. · 2003 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K990172Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…Coulter Corp. · 1999 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K963263Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome…Coulter Corp. · 1997 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 8 ancestors have a recall of any class; 4 have a Class I recall.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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 Cytomics FC 500 MPL is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file. The tetraCXP SYSTEM for Cytomics FC 500 flow cytometry systems is an automated analysis method for simultaneous identification and enumeration of lymphocyte subpopulations (CD3+, CD4+, CD8+, CD19+ and CD56+)…
Read the full statement (189 words)
The Cytomics FC 500 MPL is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file.
The tetraCXP SYSTEM for Cytomics FC 500 flow cytometry systems is an automated analysis method for simultaneous identification and enumeration of lymphocyte subpopulations (CD3+, CD4+, CD8+, CD19+ and CD56+) combining four-color fluorescent monoclonal antibody reagents, quality control reagents, optional absolute count reagent and CXP software. The systems with CYTO-STAT tetraCHROME CD45-FITC/CD4-PD/CD8-ECD/CD3-PC5 Monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of Total CD3+ (T cells), Total CD4+, Total CD8+, Dual CD3+/CD4+, Dual CD3+/CD8+ lymphocyte percentages and absolute counts as well as the CD4/CD8 ratio in whole blood flow cytometry. The systems with CD45-FITC/CD56-PC/CD19-ECD/CD3-PC5, the total lymphocyte percentage can be obtained. CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of total CD19+ (B cells) and CD3-/CD56+ (NK cells) lymphocyte percentages and absolute counts in whole blood flow cytometry. The total lymphocyte percentage can obtained as well.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182886 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182886: Cytomics FC 500 Series (MPL or MCL) Flow Cytometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182886
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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