# K183525: EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Sep 6, 2019 after 261 days
- Product code: PSV (Ultrasound Bronchoscope)
- Device class: 2
- Regulation: 21 CFR 892.1550
- 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: 9 generations back to K894632 (1989). 59 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 62 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070983: Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10 Ultrasound System, Olympus Medical Systems Corporation (2007) Summary page 4.

## Most influential descendants
- K260401: Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F) (2026), 0 descendants of its own
- K250863: FUJIFILM Ultrasonic Endoscope EB-710US (2025), 0 descendants of its own

## Recalls of this device
- Sep 25, 2023 · Class II · Z-0328-2024: 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

## Indications for use
This instrument has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, display monitor, EndoTherapy accessories such as an aspiration biopsy needle. This instrument is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound guided needle aspiration within the airways, tracheobronchial tree, and esophagus.

Source page: https://510kreport.com/device/K183525
Methodology: https://510kreport.com/methodology