# K173554: PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope

- Pathway: 510(k) (Traditional)
- Applicant: Pentax of America, Inc.
- Decided: Jan 19, 2018 after 63 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: 10 generations back to K894632 (1989). 80 ancestors in all.
No later device cites it as a predicate yet.
2 of 81 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 8.
- K162151: PENTAX Medical ENT Video Imaging System, Pentax of America, Inc. (2017) Summary page 8.
- K081518: Ultrasound Video Bronchoscope, Model EB-1970UK, Pentax Medical Company (2008) Summary page 8.

## Indications for use
Device Name: PENTAX Medical Video Bronchoscopes (EB Family): 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. The PENTAX Medical Video Naso-Pharyngo-Laryngoscope (VNL-1570STK) is designed to be used with a PENTAX Medical video processor, light source, documentation equipment, display monitor, endoscopic accessories, and other ancillary equipment and intended to provide optical visualization (via a video monitor) of, and therapeutic access to, nasal, pharyngeal, laryngeal and the upper airway anatomy. Device Name: PENTAX Medical Ultrasound Video Bronchoscopes, EB-1970UK: 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 the organs, tissues, and subsystems: Nasal Passage, Pharynx, Trachea 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/K173554
Methodology: https://510kreport.com/methodology