510(k) · Cleared
ClearedAmielle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Owen Mumford USA, Inc. · KXP Stent, Vaginal
Cleared on Nov 25, 1998 after an 85-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Nov 25, 1998
- Review
- 85 days
- Class
- Class II
- Product code
- KXP
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK983045 AmielleOwen Mumford USA, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK222492 Hope&Her Vaginal DilatorsLujena, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K222492Hope&Her Vaginal DilatorsLujena, Inc. · 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) | K983045 | Amielle | Owen Mumford USA, Inc. | 1998 | — |
| +1 | K222492 | Hope&Her Vaginal Dilators | Lujena, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 KXP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Young's Vaginal Dilator Named without a submission number |
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 |
|---|---|---|---|
| K222492 | Hope&Her Vaginal Dilators | 2023 | 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?
- Of its descendants, K222492 (Lujena, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KXP devicesKXP Stent, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KXP
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · KXP
Too few KXP 510(k)s in any year since 2007 to give a median.
Recalls per year · KXP
No recall names KXP since 2007.
Adverse event reports per year · KXP
1in 2008
MAUDE reports naming product code KXP, 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 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 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 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device is intended to trcat women suffering from vaginismus and dysparcunia. VAGINISMUS is the involuntary spasm of the muscles in the vaginal wall which then inhibits sexual intercourse by making it painful or impossible. DYSPAREUNIA is the pain experienced during sexual intercourse caused by physical and/oy emotional problems.
The device comes in varying sizes, the most appropriate is then sclected by the physician for use by the paticnt and the patient’s partner as an assistant if appropriate. It is used as a tool to DILATE the vagina in controlled stages.
The device can be autoclaved or sterilised by normal methods.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983045 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983045: Amielle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983045
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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