# K200678: PENTAX Medical Video Bronchoscope EB-J10 Series

- Pathway: 510(k) (Traditional)
- Applicant: Pentax of America, Inc.
- Decided: Jul 30, 2020 after 136 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: 8 generations back to K931154 (1993). 22 ancestors in all.
No later device cites it as a predicate yet.
2 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131028: Pentax Video Bronchoscopes (EB Family), Pentax Medical Company (2014) Summary page 4.

## Indications for use
The PENTAX Medical Video Bronchoscopes EB-J10 Series 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/K200678
Methodology: https://510kreport.com/methodology