# K001203: Olympus UM 2R/3R Ultrasonic Probe and Associated Ancillary Equipment for Female Reproductive Tract

- Pathway: 510(k) (Traditional)
- Applicant: The Olympus Optical Co.
- Decided: May 26, 2000 after 43 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
No predicates in its family tree.
61 later devices descend from it; 1 cites it directly.
1 of 62 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K001203
Methodology: https://510kreport.com/methodology