# K921244: Disposable Protective Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Vision-Sciences, Inc.
- Decided: Oct 6, 1992 after 204 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
No predicates in its family tree.
187 later devices descend from it; 4 cite it directly.
0 of 188 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K950809: Vision-Sciences Disposable Endosheath for Flexible Nasopharyngo-Laryngoscopes (1996), 184 descendants of its own
- K961591: Disposable Endosheath for E-F100 Flexible Nasopharyngoscope (1996), 184 descendants of its own
- K990354: Endosheath (1999), 180 descendants of its own
- K963795: Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable Endosheath (1996), 158 descendants of its own
- K012543: Vision Sciences Endosheath System (2002), 157 descendants of its own

Source page: https://510kreport.com/device/K921244
Methodology: https://510kreport.com/methodology