510(k) · Cleared
Recalled · Class II · 2025DxFLEX Flow Cytometer; ClearLLab 10C Panels
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · OYE Flow Cytometric Reagents And Accessories.
Cleared on Nov 22, 2023 as substantially equivalent to K183592 (Beckman Coulter, 2019) after an 86-day review. Its family tree reaches back 7 generations to 1993. 3 of the 13 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Nov 22, 2023
- Review
- 86 days
- Class
- Class II
- Product code
- OYE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K922745 (1993). 12 ancestors in all. No later device cites it as a predicate yet. 3 of the 13 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK922745 Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1Coulter Immunology · 1993
- 6 generations backK963263 Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat…Coulter Corp. · 1997 · Recalled (Class I)
- 5 generations backK990172 Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat…Coulter Corp. · 1999 · Recalled (Class I)
- 4 generations backK030828 Tetracxp System (Software and System Guide)Beckman Coulter, Inc. · 2003 · Recalled (Class I)
- 3 generations backK130373 Navios Flow Cytometer SystemBeckman Coulter, Inc. · 2013
- 2 generations backK162897 Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer…Beckman Coulter · 2017
- 1 generation backK183592 ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios…Beckman Coulter · 2019
- This deviceK232600 DxFLEX Flow Cytometer; ClearLLab 10C PanelsBeckman Coulter, Inc. · 2023
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922745 | Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1 | Coulter Immunology | 1993 | — |
| −6 | K963263 | Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome… | Coulter Corp. | 1997 | Class I |
| −5 | K990172 | Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome… | Coulter Corp. | 1999 | Class I |
| −4 | K030828 | Tetracxp System (Software and System Guide) | Beckman Coulter, Inc. | 2003 | Class I |
| −3 | K130373 | Navios Flow Cytometer System | Beckman Coulter, Inc. | 2013 | — |
| −2 | K162897 | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2… | Beckman Coulter | 2017 | — |
| −1 | K183592 | ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow… | Beckman Coulter | 2019 | — |
| 0 (this device) | K232600 | DxFLEX Flow Cytometer; ClearLLab 10C Panels | Beckman Coulter, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2017 | 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.
3 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 OYE device
- #1 K201814 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2…score -0.1 · 7 generations · no Class I recall
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 |
|---|---|---|---|
| * | K183592 | ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow CytometerSummary page 5…ication 21 CFR Number Cleared Code Navios EX Flow Cytometer K183592 03/21/2019 Class II 864.5220 OYE ClearLLab 10C Reagent System K183592 03/21/201… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 22, 2025 | Class II | Z-0541-2026 | Under Investigation by firm | Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results. |
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.
- K030828Tetracxp System (Software and System Guide)Beckman Coulter, Inc. · 2003 · 3 generations back · ◆ 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 · 4 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 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 3 of the 12 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All OYE devicesOYE Flow Cytometric Reagents And Accessories.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OYE
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OYE
Too few OYE 510(k)s in any year since 2007 to give a median.
Recalls per year · OYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OYE
40in 2025
MAUDE reports naming product code OYE, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 9 |
| 2015 | 2 | — | 0 | 6 |
| 2016 | 0 | — | 1 | 2 |
| 2017 | 2 | — | 1 | 9 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 0 | — | 10 | 6 |
| 2020 | 1 | — | 0 | 173 |
| 2021 | 0 | — | 0 | 251 |
| 2022 | 0 | — | 0 | 193 |
| 2023 | 1 | — | 0 | 141 |
| 2024 | 0 | — | 5 | 35 |
| 2025 | 0 | — | 1 | 40 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device forimmunophenotyping using up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument The ClearLLab 10C Panels are intended for in vitro diagnostic use for qualitative identification of…
Read the full statement (253 words)
The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device forimmunophenotyping using up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument
The ClearLLab 10C Panels are intended for in vitro diagnostic use for qualitative identification of cell populations by multiparameter immunophenotyping on the Navios, Navios EX and DxFLEX flow cytometers. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN). The reagents can be used with peripheral whole blood (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin), bone marrow (collected in K2EDTA, ACD or Heparin) and lymph node specimens. Interpretation of the results should be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.
These reagents provide multiparameter, qualitative results for the surface antigens listed below:
« ClearLLab 10C B Cell Tube: Kappa, Lambda, CD10, CD5, CD200, CD34, CD38, CD20, CD19, CD45
« ClearLLab 10C T Cell Tube: TCRyS, CD4, CD2, CD56, CD5, CD34, CD3, CD8, CD7, CD45
+ ClearLLab 10C M1 Cell Tube: CD16, CD7, CD10, CD13, CD64, CD34, CD14, HLA-DR, CD11b, CD45
« ClearLLab 10C M2 Cell Tube: CD15, CD123, CD117, CD13, CD33, CD34, CD38, HLA-DR, CD19, CD45
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/K232600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232600: DxFLEX Flow Cytometer; ClearLLab 10C Panels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232600
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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