# K121035: Fujinon/Fujifilm Ultrasonic Endoscope EB-530US

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Jun 4, 2012 after 60 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K894632 (1989). 49 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 52 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042140: Olympus BF Type UC160-OL8, Olympus Corporation (2004) Summary page 2.
- (no number) OLYMPUS BF type UC160F-OLB8: named in the summary without a submission number

## Most influential descendants
- K250863: FUJIFILM Ultrasonic Endoscope EB-710US (2025), 0 descendants of its own
- K182825: FUJIFILM Ultrasonic Endoscope (2019), 0 descendants of its own

## Indications for use
The Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, diagnosis and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. It is used with Fujinon/Fujifilm ultrasonic processor, video processor, light source, other peripheral equipment and endoscopic accessories. It is not intended for use on children and infants.

Source page: https://510kreport.com/device/K121035
Methodology: https://510kreport.com/methodology