# K081518: Ultrasound Video Bronchoscope, Model EB-1970UK

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Medical Company
- Decided: Sep 5, 2008 after 98 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: 9 generations back to K894632 (1989). 62 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 68 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070983: Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10 Ultrasound System, Olympus Medical Systems Corporation (2007) Summary page 1.
- K023376: EB-1830T3, Video Bronchoscope, Pentax Precision Instrument Corp. (2002) Summary page 1.
- K063518: HI Vision 900 Diagnostic Ultrasound Scanner, Hitachi Medical Systems America, Inc. (2006) Summary page 1.

## Most influential descendants
- K131946: Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin Preirus (2014), 3 descendants of its own
- 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
- K173554: PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope (2018), 0 descendants of its own

## Indications for use
Diagnostic Ultrasound imaging or fluid flow analysis of the human body

Source page: https://510kreport.com/device/K081518
Methodology: https://510kreport.com/methodology