510(k) · Cleared
ClearedUresta Pessary
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eastmed, Inc. · HHW Pessary, Vaginal
Cleared on Oct 9, 2008 as substantially equivalent to K930618 (Johnson & Johnson Medical, Inc., 1995) and 2 other predicates after a 146-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.
- Decided
- Oct 9, 2008
- Review
- 146 days
- Class
- Class II
- Product code
- HHW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K930618 (1995). 3 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK930618 Vaginal Continence DeviceJohnson & Johnson Medical, Inc. · 1995
- This deviceK081385 Uresta PessaryEastmed, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK083769 Modification to Uresta PessaryEastmed, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK240798 Cntrl+ Bladder Support PessaryCntrl+, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK232525 Yoni.Fit Bladder SupportWatkins-Conti Products, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK233548 Uresta®Resilia, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K083769Modification to Uresta PessaryEastmed, Inc. · 2009 · cites it directly1descendant
- K240798Cntrl+ Bladder Support PessaryCntrl+, Inc. · 2024 · cites it directly0descendants
- K232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc. · 2024 · 2 generations on0descendants
- K233548Uresta®Resilia, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930618 | Vaginal Continence Device | Johnson & Johnson Medical, Inc. | 1995 | — |
| 0 (this device) | K081385 | Uresta Pessary | Eastmed, Inc. | 2008 | — |
| +1 | K083769 | Modification to Uresta Pessary | Eastmed, Inc. | 2009 | — |
| +1 | K240798 | Cntrl+ Bladder Support Pessary | Cntrl+, Inc. | 2024 | — |
| +2 | K232525 | Yoni.Fit Bladder Support | Watkins-Conti Products, Inc. | 2024 | — |
| +1 | K233548 | Uresta® | Resilia, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2024 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K930618 | Vaginal Continence DeviceSummary page 1…lexible Pessary, Cooper Surgical • Milex Incontinence Ring with Knob and Support, Cooper Surgical * Introl Bladder Neck Support Prosthesis, Johnson &Johnson (K9306 18, K965040) * PelvX Incontinence Dish, Deschutes Medical Products Inc. (K990593) Description of the Device The urestai m… | 1995 |
| * | K965040 | Introl Bladder Neck Support Prosthesis with Removal ToolSummary page 1…ssary, Cooper Surgical • Milex Incontinence Ring with Knob and Support, Cooper Surgical * Introl Bladder Neck Support Prosthesis, Johnson &Johnson (K9306 18, K965040) * PelvX Incontinence Dish, Deschutes Medical Products Inc. (K990593) Description of the Device The urestai m Pessary i… | 1997 |
| * | K990593 | Pelvx Incontinence Dish, Model 301-306Summary page 1…t, Cooper Surgical * Introl Bladder Neck Support Prosthesis, Johnson &Johnson (K9306 18, K965040) * PelvX Incontinence Dish, Deschutes Medical Products Inc. (K990593) Description of the Device The urestai m Pessary is designed for adult women who experience involuntary urine loss from the… | 1999 |
| * | — | Milex Incontinence Ring, Flexible Pessary, Cooper Surgical Named without a submission number | |
| * | — | Milex Incontinence Ring with Knob and Support, Cooper Surgical Named without a submission number |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All HHW devicesHHW Pessary, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
This device is for the use in adult women, over 18 years of age who experience
involuntary urine loss with physical activity (stress urinary incontinence).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081385 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081385: Uresta Pessary.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081385
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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