# K131946: Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin Preirus

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Medical Company
- Decided: Apr 25, 2014 after 302 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K894632 (1989). 63 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 67 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081518: Ultrasound Video Bronchoscope, Model EB-1970UK, Pentax Medical Company (2008) Summary page 1.

## Most influential descendants
- K183516: PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (2019), 1 descendant of its own
- 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
- K183654: PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus (2019), 0 descendants of its own

## Recalls of this device
- May 31, 2016 · Class II · Z-0757-2017: The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and September 2015 contained the Operation and Reprocessing IFUs that were in use prior to the 2014 clearan
- Jan 11, 2011 · Class II · Z-2326-2017: This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions take
- Jan 11, 2011 · Class II · Z-2325-2017: This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions take
- Jan 11, 2011 · Class II · Z-2324-2017: This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions take

## Indications for use
The EB-1970UK, Ultrasound Video Bronchoscope, 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/K131946
Methodology: https://510kreport.com/methodology