# K050220: Evis Exera Bronchovideoscope, Olympus XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Feb 10, 2005 after 10 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 5 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K844002 (1984). 11 ancestors in all.
No later device cites it as a predicate yet.
2 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023984: Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 Series, The Olympus Optical Co. (2003) Summary page 2.
- K033222: Olympus Sterilization Trays, Olympus Winter & Ibe GmbH (2004) Summary page 2.

## Recalls of this device
- Sep 11, 2025 · Class I · Z-0062-2026: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- Oct 12, 2023 · Class I · Z-0190-2024: There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the dist
- Jul 27, 2023 · Class II · Z-2492-2023: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- Aug 16, 2021 · Class II · Z-2573-2021: 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."
- Aug 8, 2018 · Class II · Z-3302-2018: The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

## Indications for use
These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, videc monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. The XMAJ-178 is a sterilization tray intended for use in medical facilities to accommodate the Olympus autoclavable Bronchovideoscopes during autoclaving. The MAJ-1214 is attached to the electrical connector on the endoscope to protect the connector from water penetration during reprocessing. The FB-52C-1 has been designed to be used with an Olympus endoscope to collect tissue within the thoracic and abdominal cavities and the airways and tracheobrochial tree. This instrument has been designed to be used with Olympus endoscopes to retrieve foreign bodies, caluculi or tissue specimens from the digestive tract, urinary tract, female reproductive tract and respiratory organs. The Olympus IE-2P magnetic Extractor has been specially designed to be used within the airways and tracheobrochial tree. These instruments have been designed to be used with an Olympus endoscope to perform endoscopic vascular or submucosal injection within the thoracic and abdominal cavities and the airways and tracheobrochial tree. These measuring devices have been designed for measuring leisions within the thoracic and abdominal cavities and the airways and tracheobochial tree.

Source page: https://510kreport.com/device/K050220
Methodology: https://510kreport.com/methodology