# K183691: PENTAX Medical ENT Video Imaging System

- Pathway: 510(k) (Special)
- Applicant: Pentax of America, Inc.
- Decided: Jun 12, 2019 after 163 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: 8 generations back to K931154 (1993). 22 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K162151: PENTAX Medical ENT Video Imaging System, Pentax of America, Inc. (2017) Summary page 4.

## Most influential descendants
- 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-Laryngoscopes, PENTAX Medical Video Processor, PENTAX Medical Digital Video Capture Module, PENTAX Medical Laryngeal Strobe and other ancillary equipment. 1) PENTAX Medical Video Naso-Pharyngo-Laryngoscope The PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J 10 Series (VNL8-J 10, VNL 11-J 10 and VNL 15-J 10) is intended to be used with a PENTAX Medical Video Processor, PENTAX Medical Laryngeal Strobe, documentation equipment, video monitor, endoscopic device and other ancillary equipment for optical visualization (via a video monitor) of, and, for VNL15-J10 only, 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, PENTAX Medical VNL- I 570STK, VNL8-J I 0, VNL 11-J I 0, and VNL 15-J IO endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and naso-pharyngo-laryngoscopic (ENT) diagnosis, treatment and video observation with or without stroboscopy. The PENTAX Medical EPK-i5010 Video Processor includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology.

Source page: https://510kreport.com/device/K183691
Methodology: https://510kreport.com/methodology