510(k) · Cleared
Recalled · Class II · 2024BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · OYE Flow Cytometric Reagents And Accessories.
Cleared on Sep 28, 2020 as substantially equivalent to K170974 (Becton, Dickinson and Company, 2017) after an 89-day review. Its family tree reaches back 7 generations to 1996. It has been recalled 5 times.
- Decided
- Sep 28, 2020
- Review
- 89 days
- Class
- Class II
- Product code
- OYE
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 7 generations to K946055 (1996). 24 ancestors in all, the oldest K913192 (1992). No later device cites it as a predicate yet.
- Root · 7 generations backK946055 Tritest Reagent CD3 Fitc/CD4 PE/CD45 PercpBecton Dickinson Immunocytometry Systems · 1996 · Recalled
- 6 generations backK963963 Multiset Software for Automated Flow Cytometric Data AnalysisBecton Dickinson Immunocytometry Systems · 1996 · Recalled
- 5 generations backK974360 Multitest CD3/CD8/CD45/CD4Becton Dickinson Immunocytometry Systems · 1998
- 4 generations backK980858 Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing…Becton Dickinson Immunocytometry Systems · 1998 · Recalled
- 3 generations backK060375 BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models…Bd Biosciences · 2006
- 2 generations backK090967 BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 2009 · Recalled
- 1 generation backK170974 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical…Becton, Dickinson and Company · 2017 · Recalled
- This deviceK201814 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5…Becton, Dickinson and Company · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K946055 | Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp | Becton Dickinson Immunocytometry Systems | 1996 | 1 |
| −6 | K963963 | Multiset Software for Automated Flow Cytometric Data Analysis | Becton Dickinson Immunocytometry Systems | 1996 | 1 |
| −5 | K974360 | Multitest CD3/CD8/CD45/CD4 | Becton Dickinson Immunocytometry Systems | 1998 | — |
| −4 | K980858 | Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution | Becton Dickinson Immunocytometry Systems | 1998 | 1 |
| −3 | K060375 | BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166 | Bd Biosciences | 2006 | — |
| −2 | K090967 | BD Multitest 6-Color TBNK Reagent, Model 644611 | Bd Biosciences | 2009 | 3 |
| −1 | K170974 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical… | Becton, Dickinson and Company | 2017 | 17 |
| 0 (this device) | K201814 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical… | Becton, Dickinson and Company | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 5 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2015 | 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 OYE? 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
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 |
|---|---|---|---|
| * | K170974 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD…Summary page 6…eter System Components and Device Modification System component Cleared in Modification of this Special K170974 510(k) BD FACSLyric™ Flow Cytometer Yes Modified BD FACS™ Universal Loader Yes… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 1, 2024 | Class II | Z-0745-2025 | Nonconforming Material/Component | On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers… |
| Nov 1, 2024 | Class II | Z-0748-2025 | Nonconforming Material/Component | On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers… |
| Nov 1, 2024 | Class II | Z-0749-2025 | Nonconforming Material/Component | On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers… |
| Nov 1, 2024 | Class II | Z-0746-2025 | Nonconforming Material/Component | On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers… |
| Nov 1, 2024 | Class II | Z-0747-2025 | Nonconforming Material/Component | On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 12 of the 24 ancestors have a recall of any class.
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. 2020, 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 BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. The BD FACSLyric™ flow cytometer with the integrated BD FACSDuet™ Sample Preparation System is…
Read the full statement (145 words)
The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.
The BD FACSLyric™ flow cytometer with the integrated BD FACSDuet™ Sample Preparation System is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. It includes an automated sample preparation system used to prepare human peripheral whole blood samples for acquisition and analysis and is intended for use with in vitro diagnostic (1VD) assays and software that are indicated for use with the instrument.
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/K201814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201814: BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201814
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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