# K926514: Endoscopic Ultrasound System Type 20

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Corp.
- Decided: Aug 16, 1993 after 229 days
- Product code: ODG (Endoscopic Ultrasound System, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
195 later devices descend from it; 6 cite it directly.
6 of 196 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
- K951994: Olympus EU-M30 Endoscopic Ultrasound Center (1996), 148 descendants of its own
- K982323: Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use (1998), 142 descendants of its own
- K963023: Ultrasound Gastroscope GF Type UM30P (1997), 88 descendants of its own
- K971660: Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary Equipment (1997), 75 descendants of its own
- K042438: Superdimension/Bronchus (2004), 73 descendants of its own

## Recalls of this device
- Oct 16, 2020 · Class II · Z-0501-2021: A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.

Source page: https://510kreport.com/device/K926514
Methodology: https://510kreport.com/methodology