# K023376: EB-1830T3, Video Bronchoscope

- Pathway: 510(k) (Special)
- Applicant: Pentax Precision Instrument Corp.
- Decided: Oct 16, 2002 after 8 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934920 (1994). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934920: VB-1830/VB-1530, Video Bronchoscope, Pentax Precision Instrument Corp. (1994) Summary page 1.

## Most influential descendants
- K081518: Ultrasound Video Bronchoscope, Model EB-1970UK (2008), 5 descendants of its own
- 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

## Recalls of this device
- Apr 6, 2016 · Class II · Z-2076-2016: Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- Apr 6, 2016 · Class II · Z-2065-2016: Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- Sep 30, 2011 · Not classified · Z-0818-2012: The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope.

## Indications for use
The EB-1830T3, Video Bronchoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to, the Pulmonary Tract. The Pulmonary Tract includes, but is not restricted to, the organs; tissues; and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, and bronchial Tree (including access beyond the stem). The instrument is introduced per oral or per nasal when indications consistent with the requirement for the procedure are observed in adult and pediatric patient populations.

Source page: https://510kreport.com/device/K023376
Methodology: https://510kreport.com/methodology