510(k) Report

510(k) · Cleared

Cleared

BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5)

K260215510(k) TraditionalCleared Oct 20, 2026270-day reviewClass II21 CFR 864.5220

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bd Biosciences · OYE Flow Cytometric Reagents And Accessories.

Cleared on Oct 20, 2026 after a 270-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 20, 2026
Review
270 days
Class
Class II
Product code
OYE
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K260215Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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. #1 K232600 DxFLEX Flow Cytometer; ClearLLab 10C Panelsscore 6.2 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All OYE devices

OYE Flow Cytometric Reagents And Accessories.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · OYE

1in 2023

2013: 22015: 22017: 22020: 12023: 12026 (partial year): 1
2007high 2 (2013) · low 0 (2007)2026

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

2016: 12017: 12019: 102024: 52025: 1
2007high 10 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OYE

40in 2025

2013: 42014: 92015: 62016: 22017: 92018: 252019: 62020: 1732021: 2512022: 1932023: 1412024: 352025: 40
2007high 251 (2021) · low 0 (2007)2025

MAUDE reports naming product code OYE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20132—04
20140—09
20152—06
20160—12
20172—19
20180—025
20190—106
20201—0173
20210—0251
20220—0193
20231—0141
20240—535
20250—140
20261—0—

More from Bd Biosciences

11 FDA decisions under this applicant name. See the company

  • K141468BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3…Bd Biosciences · 2015
  • K090967BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 20093 recalls
  • K081213BD Facscount CD4 Reagents with Model 339010Bd Biosciences · 20082 recalls
  • K071143BD Tritest CD3/CD4/CD45, Model 340383Bd Biosciences · 20071 recall
  • K071141BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402Bd Biosciences · 2007

Recent decisions in OYE

The OYE category page

  • K232600DxFLEX Flow Cytometer; ClearLLab 10C PanelsBeckman Coulter, Inc. · 20231 recall
  • K201814BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample…Becton, Dickinson and Company · 20205 recalls
  • K170974BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical…Becton, Dickinson and Company · 201717 recalls
  • K162897Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow…Beckman Coulter · 2017
  • K141932Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol, Aquios Immuno-Trol…Beckman Coulter, Inc. · 20156 recalls

https://510kreport.com/device/K260215 · printed Nov 3, 2026

Cite this page

510(k) Report. “K260215: BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K260215

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Record history
  • FDA decision record loaded Nov 3, 2026
  • Page last updated Nov 3, 2026