# K033225: Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and Ancillary Equipment

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical Co., Ltd.
- Decided: Oct 16, 2003 after 10 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931154 (1993). 4 ancestors in all.
60 later devices descend from it; 3 cite it directly.
2 of 65 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.
- K931154: Evis 200 System, Olympus Corp. (1993) Summary page 2.

## Most influential descendants
- K042140: Olympus BF Type UC160-OL8 (2004), 43 descendants of its own
- K050503: Single Use Aspiration Needle NA-201SX-4022 (2005), 28 descendants of its own
- K051886: Olympus Choledochoscope, Model XCHF-BP160F (2005), 13 descendants of its own
- K070983: Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10 Ultrasound System (2007), 11 descendants of its own
- K090170: Spyscope Access and Delivery Catheter (2009), 10 descendants of its own

## Recalls of this device
- 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-2491-2023: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- Mar 8, 2022 · Class II · Z-1048-2022: 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-2569-2021: 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-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.

## Indications for use
The EVIS EXERA Bronchofibervideoscope Olympus BF type XP160F has 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/K033225
Methodology: https://510kreport.com/methodology