# K061313: Evis Exera 180 System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Aug 31, 2006 after 113 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 19 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K931154 (1993). 20 ancestors in all.
158 later devices descend from it; 10 cite it directly.
6 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051645: Evis Exera 160A System, Olympus Medical Systems Corporation (2005) Summary page 3.
- K023984: Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 Series, The Olympus Optical Co. (2003) Summary page 2.
- K031648: Visera Rhino-Laryngovideoscope Olympus Enf Type V, Olympus Optical Co., Ltd. (2003) Summary page 2.
- K052452: Visera Rhino-Laryngovideoscope Olympus Enf Type VT, Olympus Medical Systems Corporation (2005) Summary page 9.

## Most influential descendants
- K100584: Evis Exeraii 180 System (2010), 132 descendants of its own
- K112680: Evis Exera Iii Video System (2012), 57 descendants of its own
- K111425: Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190 (2012), 34 descendants of its own
- K123365: Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190 (2013), 19 descendants of its own
- K122831: Video System Center (2012), 19 descendants of its own

## Recalls of this device
- Jan 29, 2026 · Class II · Z-1489-2026: Potential for rubber fragment detachment during use.
- Jan 29, 2026 · Class II · Z-1488-2026: Potential for rubber fragment detachment during use.
- Sep 11, 2025 · Class I · Z-0051-2026: 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.
- Sep 11, 2025 · Class I · Z-0061-2026: 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.
- Sep 11, 2025 · Class I · Z-0046-2026: 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.
- Sep 11, 2025 · Class I · Z-0056-2026: 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-0191-2024: 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
- Sep 25, 2023 · Class II · Z-0332-2024: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the poten
- Jul 27, 2023 · Class II · Z-2493-2023: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- Jun 8, 2023 · Class I · Z-2016-2023: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
- Mar 8, 2022 · Class II · Z-1049-2022: Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendat
- Aug 16, 2021 · Class II · Z-2571-2021: 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 16, 2021 · Class II · Z-2572-2021: 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 31, 2020 · Class II · Z-3017-2020: The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient infections than other comparable OMSC bronchoscopes.
- Aug 8, 2018 · Class II · Z-3285-2018: 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.
- Aug 8, 2018 · Class II · Z-3297-2018: 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.
- Aug 8, 2018 · Class II · Z-3288-2018: 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.
- Aug 8, 2018 · Class II · Z-3301-2018: 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.
- Aug 8, 2018 · Class II · Z-3310-2018: 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
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation. This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation. These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

Source page: https://510kreport.com/device/K061313
Methodology: https://510kreport.com/methodology