# EOQ: Bronchoscope (Flexible Or Rigid)

- Device class: 2; regulation: 21 CFR 874.4680; FDA's rule: 510(k) required
- FDA decisions: 244
- 510(k) review time 2021–2025: median 145 days (middle half 86–206)
- Recalls: 69 (28 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: 4
- 2018: 7
- 2019: 11
- 2020: 10
- 2021: 15
- 2022: 11
- 2023: 12
- 2024: 13
- 2025: 20
- 2026: 9

## Most-cited predicates
- K173727: Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor (2018), cited by 16
- K931154: Evis 200 System (1993), cited by 10
- K061313: Evis Exera 180 System (2006), cited by 10
- K914181: Wang/Mill-Rose Transbronchial Aspiration Needle (1991), cited by 9
- K023984: Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 Series (2003), cited by 9
- K021344: B-F200 Bronchoscope with BSS-F21 Endosheath System (2002), cited by 7
- K981543: Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary Equipment (1998), cited by 7
- K071530: Karl Storz Video Flexible Video Ent Endoscope System (2007), cited by 5
- K191828: Vathin Video Bronchoscope System (2020), cited by 5
- K934920: VB-1830/VB-1530, Video Bronchoscope (1994), cited by 5

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