510(k) · Cleared
ClearedHope&Her Vaginal Dilators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lujena, Inc. · HDX Dilator, Vaginal
Cleared on Jun 27, 2023 as substantially equivalent to K983045 (Owen Mumford USA, Inc., 1998) after a 314-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Jun 27, 2023
- Review
- 314 days
- Class
- Class II
- Product code
- HDX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983045 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK983045 AmielleOwen Mumford USA, Inc. · 1998
- This deviceK222492 Hope&Her Vaginal DilatorsLujena, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983045 | Amielle | Owen Mumford USA, Inc. | 1998 | — |
| 0 (this device) | K222492 | Hope&Her Vaginal Dilators | Lujena, Inc. | 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 |
|---|---|---|---|
| * | K983045 | AmielleSummary page 5…III. Predicate Device Predicate Device 510(k) Number Amielle K983045 This predicate device has not been subject to a design-related recall. IV. Description of Device Hope&Her… | 1998 |
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.
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?
Hope&Her Vaginal Dilators are indicated for women who need vaginal dilation for an examination, in preparation for a surgical procedure, or for the relief of vaginismus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222492: Hope&Her 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/K222492
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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