# K031790: Slide-on Endosheath System for Sensory Testing

- Pathway: 510(k) (Traditional)
- Applicant: Vision-Sciences, Inc.
- Decided: Jul 2, 2003 after 22 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: 5 generations back to K921244 (1992). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990354: Endosheath, Vision-Sciences, Inc. (1999) Summary page 1.
- K012543: Vision Sciences Endosheath System, Vision-Sciences, Inc. (2002)
- K024095: Modification to Vision Sciences Endosheath System, Vision-Sciences, Inc. (2003)
- K964815: AP-4000, Air Pulse Sensory Stimulator, Pentax Precision Instrument Corp. (1997) Summary page 1.

## Indications for use
The Endosheath® System provides a sterile, disposable protective covering for the scope to be used during flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages. The System may also be used in conjunction with the Pentax AP-4000 Air Pulse Sensory Stimulator to elicit Laryngeal Closure Reflex (Swallow) and to measure the sensory discrimination threshold at which the reflex occurs in the area of the Upper Airway innervated by the Superior Laryngeal Nerve.

Source page: https://510kreport.com/device/K031790
Methodology: https://510kreport.com/methodology