# K222492: Hope&Her Vaginal Dilators

- Pathway: 510(k) (Traditional)
- Applicant: Lujena, Inc.
- Decided: Jun 27, 2023 after 314 days
- Product code: HDX (Dilator, 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
Longest line of descent: 1 generation back to K983045 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983045: Amielle, Owen Mumford USA, Inc. (1998) Summary page 5.

## Indications for use
Hope&Her Vaginal Dilators are indicated for women who need vaginal dilation for an examination, in preparation for a surgical procedure, or for the relief of vaginismus.

Source page: https://510kreport.com/device/K222492
Methodology: https://510kreport.com/methodology