# K050972: Vision-Sciences Ent-3000 Scope

- Pathway: 510(k) (Special)
- Applicant: Vision-Sciences, Inc.
- Decided: Apr 29, 2005 after 11 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: 3 generations back to K921244 (1992). 7 ancestors in all.
30 later devices descend from it; 3 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942265: Flexible Nasopharyngo-Laryngoscope and Endosheath, Vision-Sciences, Inc. (1995) Summary page 1.
- K990354: Endosheath, Vision-Sciences, Inc. (1999) Summary page 1.

## Most influential descendants
- K072073: Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor (2007), 29 descendants of its own
- K080622: Entity Nasoview Led Nasopharyngoscope, Model 006105 (2008), 15 descendants of its own
- K091829: PLS Portable Light Source (2009), 9 descendants of its own
- K102733: Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video Processor (2011), 7 descendants of its own
- K130503: Pathassist Led Light Fiber (2013), 6 descendants of its own

## 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 VSI Flexible ENT Scope is intended for flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.

Source page: https://510kreport.com/device/K050972
Methodology: https://510kreport.com/methodology