# K982725: Olympus MH-246R Balloon Sheath, for Female Reproductive Tract Use

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Oct 23, 1998 after 79 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 K872027 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961048: Olympus MH-246R Balloon Sheath, Olympus America, Inc. (1996) Summary page 1.

## Indications for use
Olympus MH-246R Balloon Sheath have been designed to be used with the Olympus Ultrasonic Probe UM-2R/UM-3R, for intraluminal ultrasonic imaging of the female reproductive tract.

Source page: https://510kreport.com/device/K982725
Methodology: https://510kreport.com/methodology