# K100125: Vision Sciences Flexible Ent Scope

- Pathway: 510(k) (Special)
- Applicant: Vision-Sciences, Inc.
- Decided: Feb 25, 2010 after 37 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K921244 (1992). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050972: Vision-Sciences Ent-3000 Scope, Vision-Sciences, Inc. (2005) Summary page 1.
- K091829: PLS Portable Light Source, Optim, Inc. (2009) Summary page 1.

## Recalls of this device
- Dec 27, 2011 · Not classified · Z-0928-2012: Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged.
- Dec 27, 2011 · Not classified · Z-0929-2012: Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged.

## Indications for use
The Vision Sciences' Flexible ENT Scope is intended for flexible endloscopic examination of the upper airway, vocal chords and/or nasal passages.

Source page: https://510kreport.com/device/K100125
Methodology: https://510kreport.com/methodology