# K994103: Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Gastrointestinal Tract

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Sep 5, 2000 after 274 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 K926514 (1993). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944610: Olympus Ultrasonic Probes, Olympus America, Inc. (1995) Summary page 3.
- K982610: Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract), Olympus Optical, Co. (1998) Summary page 3.
- K951994: Olympus EU-M30 Endoscopic Ultrasound Center, Olympus America, Inc. (1996) Summary page 3.
- K982323: Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use, Olympus America, Inc. (1998) Summary page 3.

## Most influential descendants
- K231666: Endoscopic Ultrasonic Probe  (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (2023), 2 descendants of its own
- K250883: Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R) (2025), 0 descendants of its own
- K250762: Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R (UM-S20-20R) (2025), 0 descendants of its own

## 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 gastrointestinal tract and surrounding organs.

Source page: https://510kreport.com/device/K994103
Methodology: https://510kreport.com/methodology