# K250762: Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R (UM-S20-20R)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Jul 11, 2025 after 120 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K926514 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231666: Endoscopic Ultrasonic Probe  (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L), FUJIFILM Healthcare Americas Corporation (2023) Summary page 6.

## Indications for use
The ULTRASONIC PROBE UM-S20-17S has been designed to be used with an endoscopic ultrasound center, a probe driving unit, and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree. Modes of operation: The Mode of Operation is B mode. Operator qualifications: Appropriately trained healthcare professionals. Device use settings: Healthcare facility The ULTRASONIC PROBE UM-S20-20R has been designed to be used with an endoscopic ultrasound center, a probe driving unit, and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree. Modes of operation: The Mode of Operation is B mode. Operator qualifications: Appropriately trained healthcare professionals. Device use settings: Healthcare facility

Source page: https://510kreport.com/device/K250762
Methodology: https://510kreport.com/methodology