# K131028: Pentax Video Bronchoscopes (EB Family)

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Medical Company
- Decided: Apr 10, 2014 after 363 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931154 (1993). 21 ancestors in all.
3 later devices descend from it; 3 cite it directly.
2 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061313: Evis Exera 180 System, Olympus Medical Systems Corporation (2006) Summary page 1.

## Most influential descendants
- K210928: PENTAX Medical Video Bronchoscope EB11-J10 (2021), 0 descendants of its own
- K200678: PENTAX Medical Video Bronchoscope EB-J10 Series (2020), 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

## Recalls of this device
- May 31, 2016 · Class II · Z-2875-2016: Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.
- 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.
- 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 PENTAX Video Bronchoscopes (EB Family) have been designed to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

Source page: https://510kreport.com/device/K131028
Methodology: https://510kreport.com/methodology