# K994106: Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Bronchial Use

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Jun 2, 2000 after 179 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982323: Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use, Olympus America, Inc. (1998) Summary page 2.
- K982610: Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract), Olympus Optical, Co. (1998) Summary page 2.
- K951994: Olympus EU-M30 Endoscopic Ultrasound Center, Olympus America, Inc. (1996) Summary page 2.
- K982733: Olympus MH-246R Balloon Sheath, for Bronchial Use, The Olympus Optical Co. (1998) Summary page 2.

## Indications for use
The OLYMPUS UM-S30-25R ULTRASONIC PROBE have been designed to be used with an OLYMPUS Endoscopic Ultrasound System for intraluminal sonographic imaging of the upper airways and tracheobronchial tree.

Source page: https://510kreport.com/device/K994106
Methodology: https://510kreport.com/methodology