# K172156: PENTAX Medical EPK-3000 Video Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Medical
- Decided: Apr 5, 2018 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: 8 generations back to K931154 (1993). 22 ancestors in all.
3 later devices descend from it; 2 cite it directly.
2 of 26 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 5.

## Most influential descendants
- 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 EPK-3000 Video Imaging System consists of PENTAX Medical VIDEO PROCESSOR EPK-3000, PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series, and other ancillary equipment. 1. PENTAX Medical VIDEO PROCESSOR EPK-3000 The PENTAX Medical VIDEO PROCESSOR EPK-3000 is intended to be used with the PENTAX VNL8-J10, VNL11-J10, and VNL15-J10 endoscopes, light sources (including strobe), video monitors and other ancillary equipment for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment and video observation. The PENTAX Medical VIDEO PROCESSOR EPK-3000 includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. 2. PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series The PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL8-J10, VNL11-J10, and VNL15-J10) are intended to be used with a PENTAX EPK-3000 Video Processor (including Light source), 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.

Source page: https://510kreport.com/device/K172156
Methodology: https://510kreport.com/methodology