# K872027: Olympus GF-UM2/EU-M2

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corp.
- Decided: Aug 17, 1987 after 83 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have 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
- K961048: Olympus MH-246R Balloon Sheath (1996), 5 descendants of its own
- K982733: Olympus MH-246R Balloon Sheath, for Bronchial Use (1998), 1 descendant of its own
- K982734: Olympus MH-246R Balloon Sheath, for Urinary Tract Use (1998), 1 descendant of its own
- K994106: Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Bronchial Use (2000), 0 descendants of its own
- K994069: Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Urinary Use (2000), 0 descendants of its own

Source page: https://510kreport.com/device/K872027
Methodology: https://510kreport.com/methodology