# K202542: Allura Vaginal Stent

- Pathway: 510(k) (Traditional)
- Applicant: Pmt Corporation
- Decided: Sep 30, 2020 after 28 days
- Product code: KXP (Stent, Vaginal)
- Device class: 2
- Regulation: 21 CFR 884.3900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Allura™ Vaginal Stent is indicated to maintain the vaginal canal following radiological treatment or surgical procedures to restore, enlarge or create a vagina.

Source page: https://510kreport.com/device/K202542
Methodology: https://510kreport.com/methodology