# K260401: Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Aug 27, 2026 after 202 days
- Product code: PSV (Ultrasound Bronchoscope)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K894632 (1989). 60 ancestors in all.
No later device cites it as a predicate yet.
1 of 61 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183525: EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F, Olympus Medical Systems Corp. (2019) Summary page 6.

## Indications for use
The EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, display monitor, endoscopic therapy accessories such as an aspiration biopsy needle. The EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound guided needle aspiration within the airways and tracheobronchial tree. It is intended for use in adult patients. Operator qualifications: Appropriately trained healthcare professionals Device use settings: Professional healthcare facility (no domestic or special environments)

Source page: https://510kreport.com/device/K260401
Methodology: https://510kreport.com/methodology