# K220035: Milli Vaginal Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Materna Medical
- Decided: Feb 27, 2023 after 418 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: 2 generations back to K130273 (2013). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211959: Milli Vaginal Dilator, Materna Medical (2021) Summary page 4.

## Most influential descendants
- K241748: Intimate Rose Vaginal Dilators (2024), 0 descendants of its own

## Indications for use
The Milli Vaginal Dilator is a tool intended for controlled dilation of the vagina. It 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/K220035
Methodology: https://510kreport.com/methodology