510(k) · Cleared
ClearedYoni.Fit Bladder Support
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Watkins-Conti Products, Inc. · HHW Pessary, Vaginal
Cleared on May 17, 2024 as substantially equivalent to K083769 (Eastmed, Inc., 2009) after a 270-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- May 17, 2024
- Review
- 270 days
- Class
- Class II
- Product code
- HHW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930618 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK930618 Vaginal Continence DeviceJohnson & Johnson Medical, Inc. · 1995
- 2 generations backK081385 Uresta PessaryEastmed, Inc. · 2008
- 1 generation backK083769 Modification to Uresta PessaryEastmed, Inc. · 2009
- This deviceK232525 Yoni.Fit Bladder SupportWatkins-Conti Products, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930618 | Vaginal Continence Device | Johnson & Johnson Medical, Inc. | 1995 | — |
| −2 | K081385 | Uresta Pessary | Eastmed, Inc. | 2008 | — |
| −1 | K083769 | Modification to Uresta Pessary | Eastmed, Inc. | 2009 | — |
| 0 (this device) | K232525 | Yoni.Fit Bladder Support | Watkins-Conti Products, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1999 | 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 HHW? 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 HHW device
- #1 K253698 Milex™ Incontinence Dish Pessaries; Milex™…score 11.0 · 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 |
|---|---|---|---|
| * | K083769 | Modification to Uresta PessarySummary page 5…ation Panel – Obstetrical/Gynecological • Device Class – 2 • Regulation Number and Name – 21 CFR § 884.3575 Vaginal pessary Predicate Device: Uresta™ Pessary (K083769) Note: The predicate has not been subject to a design-related recall. Reference Device: Poise Impressa (K131198)… | 2009 |
| † | K131198 | Tipi Otc | 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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 13.4 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All HHW devicesHHW Pessary, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · HHW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HHW
263in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HHW
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HHW
39in 2025
MAUDE reports naming product code HHW, 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 | 4 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 1 | — | 9 | 0 |
| 2014 | 2 | — | 2 | 5 |
| 2015 | 1 | — | 1 | 1 |
| 2016 | 1 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 401 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 5 | 263 | 0 | 6 |
| 2025 | 1 | — | 0 | 39 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Yōni.Fit® Bladder Support is intended for the temporary management of urine leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232525: Yoni.Fit Bladder Support.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232525
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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