# K231889: Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)

- Pathway: 510(k) (Traditional)
- Applicant: Ultrasound Biotechnology (Shanghai) Co., Ltd.
- Decided: Dec 21, 2023 after 177 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K926514 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951994: Olympus EU-M30 Endoscopic Ultrasound Center, Olympus America, Inc. (1996) Summary page 5.
- K944610: Olympus Ultrasonic Probes, Olympus America, Inc. (1995) Summary page 5.

## Indications for use
Endoscopic Ultrasonic Diagnostic Equipment/Disposable Sterile Ultrasonic Probe is intended to be used in conjunction with ultrasound endoscopes to acquire and display real-time ultrasound images of the target organs. This device is indicated for intraluminal ultrasound imaging of the upper respiratory tract and bronchus, digestive tract, and hepatobiliary and pancreatic organs. Mode of operation includes B mode. This device is intended for use by a qualified and trained healthcare professional in a hospital setting or medical clinic.

Source page: https://510kreport.com/device/K231889
Methodology: https://510kreport.com/methodology