# K171011: PENTAX Medical VIVIDEO ENT Videoscope Solution

- Pathway: 510(k) (Traditional)
- Applicant: Pentax Medical
- Decided: Jul 18, 2018 after 470 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: 2 generations back to K072387 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103467: Cmos Video Rhino-Laryngoscope System Model 11101CM, KARL STORZ Endoscopy-America, Inc. (2012) Summary page 4.

## Indications for use
The PENTAX Medical VIVIDEO ENT Videoscope Solution includes the VIDEO NASO-PHARYNGO-LARYNGOSCOPE VNL9-CP and VIVIDEO VIDEO PROCESSOR CP-1000. It is intended to be used with a medical video monitor for endoscopic examination between the upper respiratory tracts of the nasal passage and the vocal cords. This PENTAX Medical VIVIDEO ENT Videoscope Solution must only be used in a clinical or ambulatory medical environment.

Source page: https://510kreport.com/device/K171011
Methodology: https://510kreport.com/methodology