# K231430: Intimate Rose Vaginal Dilators

- Pathway: 510(k) (Traditional)
- Applicant: Plus EV Holdings Dba Intimate Rose
- Decided: Jun 7, 2023 after 21 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 K130273 (2013). 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)
- K130273: Panpac Vaginal Dilators, Panpac Medical Corporation (2013) Summary page 4.

## Indications for use
The Intimate Rose Vaginal Dilators are tools intended to dilate the vagina in controlled stages to help relieve symptoms of vaginismus.

Source page: https://510kreport.com/device/K231430
Methodology: https://510kreport.com/methodology