# K994069: Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Urinary Use

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Jun 2, 2000 after 183 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: 3 generations back to K872027 (1987). 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)
- K982610: Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract), Olympus Optical, Co. (1998) Summary page 2.
- K982734: Olympus MH-246R Balloon Sheath, for Urinary Tract Use, The Olympus Optical Co. (1998) Summary page 2.

## Indications for use
The Olympus UM-S30-25R Ultrasonic Probe has been designed to be used with an Olympus Endoscopic Ultrasound center, Probe Driving Unit and an endoscope for intraluminal ultrasonic imaging of the urinary tract.

Source page: https://510kreport.com/device/K994069
Methodology: https://510kreport.com/methodology