# EOB: Nasopharyngoscope (Flexible Or Rigid)

- Device class: 2; regulation: 21 CFR 874.4760; FDA's rule: 510(k) required
- FDA decisions: 163
- 510(k) review time 2021–2025: median 198 days (middle half 152–281)
- Recalls: 5 (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)
- 2017: 6
- 2018: 6
- 2019: 8
- 2020: 3
- 2021: 2
- 2022: 6
- 2023: 3
- 2024: 2
- 2025: 3
- 2026: 5

## Most-cited predicates
- K990354: Endosheath (1999), cited by 12
- K013591: Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment (2001), cited by 7
- K103467: Cmos Video Rhino-Laryngoscope System Model 11101CM (2012), cited by 6
- K072073: Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor (2007), cited by 6
- K102733: Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video Processor (2011), cited by 5
- K012543: Vision Sciences Endosheath System (2002), cited by 4
- K942265: Flexible Nasopharyngo-Laryngoscope and Endosheath (1995), cited by 4
- K961591: Disposable Endosheath for E-F100 Flexible Nasopharyngoscope (1996), cited by 4
- K933247: Protective Sheath for Flexible Nasophary/Larygnos (1993), cited by 4
- K921244: Disposable Protective Sheath (1992), cited by 4

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