# K130273: Panpac Vaginal Dilators

- Pathway: 510(k) (Traditional)
- Applicant: Panpac Medical Corporation
- Decided: Aug 8, 2013 after 185 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices 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.

## Most influential descendants
- K211959: Milli Vaginal Dilator (2021), 2 descendants of its own
- K220035: Milli Vaginal Dilator (2023), 1 descendant of its own
- K241748: Intimate Rose Vaginal Dilators (2024), 0 descendants of its own
- K231430: Intimate Rose Vaginal Dilators (2023), 0 descendants of its own

## Indications for use
Panpac Vaginal Dilators are indicated for women who need vaginal dilation for an examination, a surgical procedure, or for the relief of vaginismus. Panpac Vaginal Dilators has tour different size (small, medium, large and extra large) in three family types; Family A, Family B and Family C with variant sizes.

Source page: https://510kreport.com/device/K130273
Methodology: https://510kreport.com/methodology