510(k) · Cleared
ClearedModification to Uresta 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 Jan 14, 2009 as substantially equivalent to K081385 (Eastmed, Inc., 2008) and 1 other predicate after a 27-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Jan 14, 2009
- Review
- 27 days
- Class
- Class II
- Product code
- HHW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K930618 (1995). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK930618 Vaginal Continence DeviceJohnson & Johnson Medical, Inc. · 1995
- 1 generation backK081385 Uresta PessaryEastmed, Inc. · 2008
- This deviceK083769 Modification to Uresta PessaryEastmed, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK232525 Yoni.Fit Bladder SupportWatkins-Conti Products, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K232525Yoni.Fit Bladder SupportWatkins-Conti Products, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930618 | Vaginal Continence Device | Johnson & Johnson Medical, Inc. | 1995 | — |
| −1 | K081385 | Uresta Pessary | Eastmed, Inc. | 2008 | — |
| 0 (this device) | K083769 | Modification to Uresta Pessary | Eastmed, Inc. | 2009 | — |
| +1 | 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 |
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 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? (2)
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 |
|---|---|---|---|
| * | K081385 | Uresta PessarySummary page 1…............. ..... Predicate Device: Substantial equivalence is claimed to the following devices: TM * uresta Pessary, K081385, EastMed Inc. • Instead Softcup - Feminine Protection Cup, K971303, Ultrafem Inc. Description of the Device… | 2008 |
| * | K971303 | Instead, SoftcupSummary page 1…owing devices: TM * uresta Pessary, K081385, EastMed Inc. • Instead Softcup - Feminine Protection Cup, K971303, Ultrafem Inc. Description of the Device The urestaTM Pessary has been modified to be manufactured using an alternate non-late… | 1997 |
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 |
|---|---|---|---|
| K232525 | Yoni.Fit Bladder Support | 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 14 years and passes through 2 companies; a new generation was cleared every 13.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K232525 (Watkins-Conti Products, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K081385.
How does its category compare?
All HHW devicesHHW Pessary, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 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/K083769 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083769: Modification to 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/K083769
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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