# K982610: Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Optical, Co.
- Decided: Nov 16, 1998 after 112 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: 2 generations back to K926514 (1993). 4 ancestors in all.
67 later devices descend from it; 6 cite it directly.
1 of 72 devices in its family (counting itself) has 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 1.
- K944610: Olympus Ultrasonic Probes, Olympus America, Inc. (1995) Summary page 1.
- K926514: Endoscopic Ultrasound System Type 20, Olympus Corp. (1993) Summary page 1.
- K882061: Olympus GF-UM3/EU-M3, Olympus Corp. (1988) Summary page 1.

## Most influential descendants
- K011886: Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic Gastrovideoscope Olympus GF Type UM 160, (2001), 60 descendants of its own
- K021204: Olympus BF Type UM40 (2002), 44 descendants of its own
- K042140: Olympus BF Type UC160-OL8 (2004), 43 descendants of its own
- K050503: Single Use Aspiration Needle NA-201SX-4022 (2005), 28 descendants of its own
- K043275: Olympus EU-M60 Eus Exera Endoscopic Ultrasound Center (2004), 16 descendants of its own

## Indications for use
New indications=Intraluminal ultrasound for urinary tract. Previously cleared indications=Intraluminal ultrasound for gastrointestinal tract.

Source page: https://510kreport.com/device/K982610
Methodology: https://510kreport.com/methodology