# K254133: ENTity USB Videoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Optim, LLC
- Decided: May 14, 2026 after 143 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: 3 generations back to K072387 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200609: ENTity WiFi Video Nasopharyngoscope System, Optim, LLC (2021) Summary page 5.

## Indications for use
The Optim ENTity USB Videoscope is intended to be used for oral or nasal introduction for the examination of the upper airway from the nasal passage to the vocal cords.

Source page: https://510kreport.com/device/K254133
Methodology: https://510kreport.com/methodology