510(k) · Cleared
ClearedPanpac Vaginal Dilators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Panpac Medical Corporation · HDX Dilator, Vaginal
Cleared on Aug 8, 2013 after a 185-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Aug 8, 2013
- Review
- 185 days
- Class
- Class II
- Product code
- HDX
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK130273 Panpac Vaginal DilatorsPanpac Medical Corporation · 2013
- Descendant · cites it directly · 2 of its ownK211959 Milli Vaginal DilatorMaterna Medical · 2021
- Descendant · 2 generations on · 1 of its ownK220035 Milli Vaginal DilatorMaterna Medical · 2023
- Descendant · 3 generations on · 0 of its ownK241748 Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose · 2024
- Descendant · cites it directly · 0 of its ownK231430 Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose · 2023
Most influential descendants
Showing 4 of 4 · See all- K211959Milli Vaginal DilatorMaterna Medical · 2021 · cites it directly2descendants
- K220035Milli Vaginal DilatorMaterna Medical · 2023 · 2 generations on1descendant
- K241748Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose · 2024 · 3 generations on0descendants
- K231430Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K130273 | Panpac Vaginal Dilators | Panpac Medical Corporation | 2013 | — |
| +1 | K211959 | Milli Vaginal Dilator | Materna Medical | 2021 | — |
| +2 | K220035 | Milli Vaginal Dilator | Materna Medical | 2023 | — |
| +3 | K241748 | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | 2024 | — |
| +1 | K231430 | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HDX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HDX device
- #1 K241748 Intimate Rose Vaginal Dilatorsscore 8.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K211959 (Materna Medical, 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HDX devicesHDX Dilator, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HDX
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HDX
314in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HDX
No recall names HDX since 2007.
Adverse event reports per year · HDX
1in 2025
MAUDE reports naming product code HDX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 3 | 314 | 0 | 1 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K130273 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130273: Panpac Vaginal Dilators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130273
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026