# K023984: Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 Series

- Pathway: 510(k) (Traditional)
- Applicant: The Olympus Optical Co.
- Decided: Jan 31, 2003 after 60 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 45 (14 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931154 (1993). 3 ancestors in all.
350 later devices descend from it; 9 cite it directly.
13 of 354 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910423: Bronchoscope BF-N20, Olympus Corp. (1991) Summary page 1.
- K963033: BF 240/P240/IT240 Bronchovideoscope & Accessories, Olympus America, Inc. (1996) Summary page 2.

## Most influential descendants
- 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
- K130845: Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview (2013), 64 descendants of its own

## Recalls of this device
- Sep 11, 2025 · Class I · Z-0065-2026: 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-0045-2026: 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-0055-2026: 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-0058-2026: 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-0059-2026: 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-0054-2026: 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-0047-2026: 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-0064-2026: 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-0067-2026: 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-0189-2024: 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-0327-2024: 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-2490-2023: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- Jun 8, 2023 · Class I · Z-2013-2023: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
- Jun 8, 2023 · Class I · Z-2014-2023: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
- Jun 8, 2023 · Class I · Z-2011-2023: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
- Jun 8, 2023 · Class I · Z-2012-2023: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
- Mar 8, 2022 · Class II · Z-1047-2022: 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
- Mar 8, 2022 · Class II · Z-1046-2022: 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 17, 2021 · Class II · Z-2497-2021: A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.
- Aug 16, 2021 · Class II · Z-2565-2021: 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-2567-2021: 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-2566-2021: 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-2568-2021: 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-2570-2021: 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-3309-2018: 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-3295-2018: 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-3294-2018: 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-3287-2018: 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-3299-2018: 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-3300-2018: 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-3290-2018: 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-3306-2018: 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-3307-2018: 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-3296-2018: 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-3308-2018: 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-3283-2018: 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-3284-2018: 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-3298-2018: 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-3293-2018: 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-3305-2018: 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-3292-2018: 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-3291-2018: 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-3289-2018: 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-3312-2018: 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-3286-2018: 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
< BF-40 Series> These instruments have been designed to be used with an Olympus Light Source, documentation equipment, display monitor, Endo-Therapy Accessories and other ancillary equipment for endoscopic diagnostic and treatment within the airways and tracheobronchial tree. <BF-240 Series> This instrument has been designed to be used with an Olympus Video System Center, Light Source, Documentation Equipment, Display monitor, Endo-Therapy Accessories, Electrosurgical Unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree. <BF-160 Series> These instrument have been designed to be used with an OLYMPUS video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

Source page: https://510kreport.com/device/K023984
Methodology: https://510kreport.com/methodology