# K910423: Bronchoscope BF-N20

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corp.
- Decided: Apr 29, 1991 after 89 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
352 later devices descend from it; 2 cite it directly.
13 of 353 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023984: Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 Series (2003), 350 descendants of its own
- K031648: Visera Rhino-Laryngovideoscope Olympus Enf Type V (2003), 159 descendants of its own
- K061313: Evis Exera 180 System (2006), 158 descendants of its own
- K100584: Evis Exeraii 180 System (2010), 132 descendants of its own
- K042438: Superdimension/Bronchus (2004), 73 descendants of its own

## Recalls of this device
- Jul 27, 2023 · Class II · Z-2502-2023: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- Aug 16, 2021 · Class II · Z-2564-2021: The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

Source page: https://510kreport.com/device/K910423
Methodology: https://510kreport.com/methodology
