# K220465: PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10

- Pathway: 510(k) (Traditional)
- Applicant: Pentax of America, Inc.
- Decided: Nov 16, 2022 after 272 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: 10 generations back to K931154 (1993). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172156: PENTAX Medical EPK-3000 Video Imaging System, Pentax Medical (2018) Summary page 6.
- K182846: PENTAX Medical EPK-3000 Video Imaging System, Pentax of America, Inc. (2019) Summary page 6.
- K183691: PENTAX Medical ENT Video Imaging System, Pentax of America, Inc. (2019) Summary page 6.

## Most influential descendants
- 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 Processor is intended to be used with the PENTAX Medical camera heads with PENTAX sinuscopes (8890, 8891, 8892, 8893), PENTAX Medical VNL8-J1O, VNL1-J10, and VNL15-J1O endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and ENT diagnosis, treatment and video observation with or without stroboscopy. The PENTAX Medical EPK-3000 Video Processor includes PENTAX i-ScanTm, 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. The PENTAX Medical Video Processor (EPK-i5010) is intended to be used with the PENTAX Medical camera heads with PENTAX sinuscopes (8890, 8891, 8892, 8893), PENTAX Medical VNL-1570STK, VNL8-J10, VNL11- J10, and VNL15-J1O endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and ENT diagnosis, treatment and video observation with or without stroboscopy. The PENTAX Medical EPK-i5010 Video Processor includes PENTAX i- Scann, a digital, post-processing imaging enhancement technology.

Source page: https://510kreport.com/device/K220465
Methodology: https://510kreport.com/methodology