510(k) · Cleared
ClearedIntimate Rose Vaginal Dilators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus EV Holdings Dba Intimate Rose · HDX Dilator, Vaginal
Cleared on Jun 7, 2023 as substantially equivalent to K130273 (Panpac Medical Corporation, 2013) after a 21-day review. Its family tree reaches back 1 generation to 2013.
- Decided
- Jun 7, 2023
- Review
- 21 days
- Class
- Class II
- Product code
- HDX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K130273 (2013). No later device cites it as a predicate yet.
- Root · 1 generation backK130273 Panpac Vaginal DilatorsPanpac Medical Corporation · 2013
- This deviceK231430 Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K130273 | Panpac Vaginal Dilators | Panpac Medical Corporation | 2013 | — |
| 0 (this device) | K231430 | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130273 | Panpac Vaginal DilatorsSummary page 4…l) Classification Panel: Obstetrics/Gynecology III. PREDICATE DEVICE 510(k) Number Trade or Proprietary Name Manufacturer K130273 Vaginal Dilators Panpac This predicate device has not been subject to a design-… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K130273.
How does its category compare?
All HDX devicesHDX Dilator, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
The Intimate Rose Vaginal Dilators are tools intended to dilate the vagina in controlled stages to help relieve symptoms of vaginismus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231430: Intimate Rose 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/K231430
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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