510(k) · Cleared
ClearedNavios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter · OYE Flow Cytometric Reagents And Accessories.
Cleared on Jun 23, 2017 as substantially equivalent to K130373 (Beckman Coulter, Inc., 2013) after a 249-day review. Its family tree reaches back 5 generations to 1993. 3 of the 12 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Jun 23, 2017
- Review
- 249 days
- Class
- Class II
- Product code
- OYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K922745 (1993). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly. 3 of the 12 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 backK130373 Navios Flow Cytometer SystemBeckman Coulter, Inc. · 2013
- This deviceK162897 Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer…Beckman Coulter · 2017
- Descendant · cites it directly · 1 of its ownK183592 ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios…Beckman Coulter · 2019
- Descendant · 2 generations on · 0 of its ownK232600 DxFLEX Flow Cytometer; ClearLLab 10C PanelsBeckman Coulter, Inc. · 2023 · Recalled
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView 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 | K130373 | Navios Flow Cytometer System | Beckman Coulter, Inc. | 2013 | — |
| 0 (this device) | 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 | — |
| +2 | K232600 | DxFLEX Flow Cytometer; ClearLLab 10C Panels | Beckman Coulter, Inc. | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 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 K232600 DxFLEX Flow Cytometer; ClearLLab 10C Panelsscore 6.2 · 7 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K130373 | Navios Flow Cytometer SystemSummary page 7…ation: Class II Classification Name: Automated Differential Cell Counter (21 CFR 864.5220) Product Code: OYE Panel: Hematology Original 510(k) Clearance / Predicate: K130373, SE date: September 18, 2013 Trade Name: Navios EX tetra Software Classification: Class II Classification Name: Automated Dif… | 2013 |
| * | — | CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT tetraCHROME… Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183592 | ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer | 2019 | 1 |
Has anything in its family been recalled? (3 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.
- K030828Tetracxp System (Software and System Guide)Beckman Coulter, Inc. · 2003 · 2 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 · 3 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 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 3 of the 9 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K183592 (Beckman Coulter, 2019) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K130373.
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. 2017, 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 Navios EX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to four fluorescent detection channels using a blue (488 nm) laser 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. CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT tetraCHROME…
Read the full statement (298 words)
The Navios EX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to four fluorescent detection channels using a blue (488 nm) laser 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.
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT tetraCHROME CD45-FITC/CDS56-RD1/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents are for use on the COULTER EPICS XI/XL-MCL, Cytomics FC 500, Navios and Navios EX Flow Cytometers. The reagents are also used with the tetraONE System for COULTER EPICS XL/XL-MCL Flow Cytometer, the tetraCXP System for FC 500 Flow Cytometry System, Navios tetra Software for the Navios System, and Navios EX tetra Software for the Navios EX System,
Used alone or in combination with the automated systems, the reagents are intended "For In Vitro Diagnostic Use"
and allow simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+CD4+, dual CD3+CD8+ and/or total CD3+, CD19+ and CD3-CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/CD8-ECD/CD3-PCS. These reagents are indicated for use in the immunologic assessment of patients having or suspected of having immune deficiency.
Flow-Set Pro Fluorospheres is a suspension of fluorescent microspheres used as an aid in standardizing forward scatter, side scatter, and fluorescence detectors (FL1-4) on the Cytomics FC 500, Navios and Navios EX Flow Cytometers.
Flow-Count Fluorospheres is a fluorescent microsphere reagent for direct determination of lymphocytes and lymphocyte subsets cell population percentages and absolute counts in biological specimens using EPICS XL/XL-MCL, Cytomics FC500, Navios and Navios EX flow cytometry systems as well as CD34+ cell population percentages and absolute counts in biological specimens using EPICS XL/XL-MCL and Cytomics FC500 flow cytometry systems.
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/K162897 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162897: Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162897
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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