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 Aug 14, 2024 as substantially equivalent to K220035 (Materna Medical, 2023) after a 57-day review. Its family tree reaches back 3 generations to 2013.
- Decided
- Aug 14, 2024
- Review
- 57 days
- Class
- Class II
- Product code
- HDX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K130273 (2013). No later device cites it as a predicate yet.
- Root · 3 generations backK130273 Panpac Vaginal DilatorsPanpac Medical Corporation · 2013
- 2 generations backK211959 Milli Vaginal DilatorMaterna Medical · 2021
- 1 generation backK220035 Milli Vaginal DilatorMaterna Medical · 2023
- This deviceK241748 Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose · 2024
View FIG. 1 as a table
Line of descent and top descendants
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 K220035 Milli Vaginal Dilatorscore 8.2 · 2 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 |
|---|---|---|---|
| * | K220035 | Milli Vaginal DilatorSummary page 5…imate Rose Vaginal Dilators Common Name: Vaginal Dilators Classification Name: Vaginal stent Classification Number: 884.3900 Product Code(s): HDX Predicate Device: 1. K220035, Milli Vaginal Dilator, Product Code HDX The predicate device has not been subject to a design-related recall. Reference Device… | 2023 |
| † | K231430 | Intimate Rose Vaginal Dilators | 2023 |
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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All HDX devicesHDX Dilator, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241748 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241748: Intimate Rose Vaginal Dilators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241748
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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