# OYE: Flow Cytometric Reagents And Accessories.

- Device class: 2; regulation: 21 CFR 864.5220; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 86 days (middle half 86–86)
- Recalls: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 2
- 2015: 2
- 2017: 2
- 2020: 1
- 2023: 1
- 2026: 1

## Most-cited predicates
- K130373: Navios Flow Cytometer System (2013), cited by 2
- K170974: 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), cited by 1
- 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 (2017), cited by 1
- K141468: BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) (2015), cited by 1

Source page: https://510kreport.com/product-code/OYE
Data by year (CSV): https://510kreport.com/product-code/OYE.csv