# K241748: Intimate Rose Vaginal Dilators

- Pathway: 510(k) (Traditional)
- Applicant: Plus EV Holdings Dba Intimate Rose
- Decided: Aug 14, 2024 after 57 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: 3 generations back to K130273 (2013). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220035: Milli Vaginal Dilator, Materna Medical (2023) Summary page 5.

## Indications for use
The Intimate Rose Vaginal Dilators are tools intended for controlled dilation of the vagina. They can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.

Source page: https://510kreport.com/device/K241748
Methodology: https://510kreport.com/methodology