# K042140: Olympus BF Type UC160-OL8

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corporation
- Decided: Aug 18, 2004 after 9 days
- Product code: ODG (Endoscopic Ultrasound System, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K894632 (1989). 48 ancestors in all.
43 later devices descend from it; 3 cite it directly.
2 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021204: Olympus BF Type UM40, Olympus Optical Co., Ltd. (2002) Summary page 2.
- K033225: Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and Ancillary Equipment, Olympus Optical Co., Ltd. (2003) Summary page 2.
- K010591: Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center, Olympus Optical Co., Ltd. (2001) Summary page 3.
- K031347: Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8, Olympus Optical Co., Ltd. (2003)

## Most influential descendants
- K050503: Single Use Aspiration Needle NA-201SX-4022 (2005), 28 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
- K093195: Echotip Ultra Endobronchial High Definition Ultasound Needle, Model: Echo-HD-22-Ebus-O (2010), 8 descendants of its own
- K160229: Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle (2016), 7 descendants of its own
- K142909: Flexible 19G EBUS Needle (2015), 7 descendants of its own

## Recalls of this device
- Aug 8, 2018 · Class II · Z-3303-2018: 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
Endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures as follows:

Source page: https://510kreport.com/device/K042140
Methodology: https://510kreport.com/methodology