FDA product code OYE: Flow Cytometric Reagents And Accessories.
OYE is the FDA product code for flow cytometric reagents and accessories.. It is a Class II device, regulated under 21 CFR 864.5220 and reviewed by the Hematology panel. FDA has cleared 8 510(k) submissions under OYE, 1 in the last five years, from 4 different applicants. The average 510(k) review took 213 days (median 232). FDA has posted 26 recalls for OYE devices, 7 initiated in the last five years.
Definition
To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer.
Classification
| Field | Value |
|---|---|
| Device name | Flow Cytometric Reagents And Accessories. |
| Device class | Class II |
| Regulation | 21 CFR 864.5220 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OYE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 170 |
| 2020 | 1 | 89 |
| 2023 | 1 | 86 |
Compare with all 510(k) review times · Search every OYE clearance
Top OYE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Coulter, Inc. | 4 | 2023-11-22 |
| Becton, Dickinson and Company | 2 | 2020-09-28 |
| Beckman Coulter | 1 | 2017-06-23 |
| Bd Biosciences | 1 | 2015-02-27 |
Most recent OYE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232600 | Beckman Coulter, Inc. | DxFLEX Flow Cytometer; ClearLLab 10C Panels | 2023-11-22 | 86 |
| K201814 | Becton, Dickinson and Company | 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 | 2020-09-28 | 89 |
| K170974 | Becton, Dickinson and Company | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK | 2017-07-03 | 91 |
| K162897 | Beckman Coulter | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser | 2017-06-23 | 249 |
| K141932 | Beckman Coulter, Inc. | AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS | 2015-04-10 | 268 |
Recalls for OYE devices
26 product recalls in 14 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2025-09-22.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 2 |
| 2019 | 10 |
| 2024 | 6 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code OYE?
OYE is the FDA product code for flow cytometric reagents and accessories.. It is a Class II device, regulated under 21 CFR 864.5220 and reviewed by the Hematology panel.
What device class is OYE?
Class II, regulation 21 CFR 864.5220. Typical premarket route: 510(k).
How long does a 510(k) take for product code OYE?
Across 8 cleared submissions the average was 213 days from receipt to decision (median 232).
Which companies have the most OYE clearances?
Beckman Coulter, Inc. (4); Becton, Dickinson and Company (2); Beckman Coulter (1); Bd Biosciences (1).
Have OYE devices been recalled?
Yes: 26 product recalls across 14 recall events; the most recent began 2025-09-22.
Next steps
- Run an FDA pathway report with predicate devices for product code OYE
- Run a recall and safety report across every OYE manufacturer
- Watch product code OYE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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