# K183516: PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U

- Pathway: 510(k) (Traditional)
- Applicant: Pentax of America, Inc.
- Decided: Sep 6, 2019 after 262 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: 11 generations back to K894632 (1989). 64 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 66 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131946: Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin Preirus, Pentax Medical Company (2014) Summary page 7.

## Most influential descendants
- K203166: PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (2020), 0 descendants of its own

## Indications for use
The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Source page: https://510kreport.com/device/K183516
Methodology: https://510kreport.com/methodology