# K162151: PENTAX Medical ENT Video Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Pentax of America, Inc.
- Decided: Apr 20, 2017 after 261 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- Recalls of this device: none
- 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.
6 later devices descend from it; 3 cite it directly.
2 of 28 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 4.

## Most influential descendants
- K172156: PENTAX Medical EPK-3000 Video Imaging System (2018), 3 descendants of its own
- K183691: PENTAX Medical ENT Video Imaging System (2019), 2 descendants of its own
- K182846: PENTAX Medical EPK-3000 Video Imaging System (2019), 2 descendants of its own
- K220465: PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10 (2022), 1 descendant of its own
- K243380: Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500) (2025), 0 descendants of its own

## Indications for use
PENTAX Medical ENT Video Imaging System consists of PENTAX Medical Video Naso-Pharyngo-Laryngoscope, PENTAX Medical Video Processor and other ancillary equipment. 1. PENTAX Medical Video Naso-Pharyngo-Laryngoscope The PENTAX Medical Video Naso-Pharyngo-Laryngoscopes (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. 2. PENTAX Medical Video Processor The PENTAX Medical Video Processor (EPK-i5010) is intended to be used with the PENTAX Medical camera heads, compatible endoscopes, light sources, monitors and other ancillary equipment for ENT endoscopic observation and diagnosis, and naso-pharyngo-laryngoscopic diagnosis, and treatment. The PENTAX Medical EPK-i5010 includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology.

Source page: https://510kreport.com/device/K162151
Methodology: https://510kreport.com/methodology