510(k) · Cleared
ClearedMilli Vaginal Dilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materna Medical · HDX Dilator, Vaginal
Cleared on Feb 27, 2023 as substantially equivalent to K211959 (Materna Medical, 2021) after a 418-day review. Its family tree reaches back 2 generations to 2013. 1 later device descends from it.
- Decided
- Feb 27, 2023
- Review
- 418 days
- Class
- Class II
- Product code
- HDX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K130273 (2013). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK130273 Panpac Vaginal DilatorsPanpac Medical Corporation · 2013
- 1 generation backK211959 Milli Vaginal DilatorMaterna Medical · 2021
- This deviceK220035 Milli Vaginal DilatorMaterna Medical · 2023
- Descendant · cites it directly · 0 of its ownK241748 Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose · 2024
Most influential descendants
Showing 1 of 1 · See all- K241748Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K130273 | Panpac Vaginal Dilators | Panpac Medical Corporation | 2013 | — |
| −1 | K211959 | Milli Vaginal Dilator | Materna Medical | 2021 | — |
| 0 (this device) | K220035 | Milli Vaginal Dilator | Materna Medical | 2023 | — |
| +1 | K241748 | Intimate Rose Vaginal Dilators | Plus EV Holdings Dba Intimate Rose | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
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 |
|---|---|---|---|
| * | K211959 | Milli Vaginal DilatorSummary page 4…Name: Vaginal Stent (21 CFR 884.3900) Regulatory Class: II Product Code: HDX III. PREDICATE DEVICE The predicate device is the Milli Vaginal Dilator cleared under K211959. The predicate device has not been subject to a design-related recall. IV. DEVICE DESCRIPTION The Milli Vaginal Dilator i… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241748 | Intimate Rose Vaginal Dilators | 2024 | 0 |
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 10 years and passes through 2 companies; a new generation was cleared every 8.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K241748 (Plus EV Holdings Dba Intimate Rose, 2024) has gone furthest, with 0 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. 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220035: Milli Vaginal Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220035
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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