510(k) · Cleared
ClearedPelvx Incontinence Ring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deschutes Medical Products, Inc. · HHW Pessary, Vaginal
Cleared on Apr 27, 1998 after a 178-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Apr 27, 1998
- Review
- 178 days
- Class
- Class II
- Product code
- HHW
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK974116 Pelvx Incontinence RingDeschutes Medical Products, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK993308 Mentor Evacare Vaginal PessariesMentor Corp. · 1999
- Descendant · 2 generations on · 0 of its ownK253698 Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish…Cooper Surgical · 2026
- Descendant · 2 generations on · 0 of its ownK250438 CooperSurgical Milex® PessariesCooperSurgical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK231786 Gynethotics™ PessaryCosm Medical · 2024
- Descendant · cites it directly · 0 of its ownK020512 Mti ST#1 Silicone PessaryMedical Technology and Innovations, Inc. · 2002
Most influential descendants
Showing 5 of 5 · See all- K993308Mentor Evacare Vaginal PessariesMentor Corp. · 1999 · cites it directly2descendants
- K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support…Cooper Surgical · 2026 · 2 generations on0descendants
- K250438CooperSurgical Milex® PessariesCooperSurgical, Inc. · 2025 · 2 generations on0descendants
- K231786Gynethotics™ PessaryCosm Medical · 2024 · cites it directly0descendants
- K020512Mti ST#1 Silicone PessaryMedical Technology and Innovations, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974116 | Pelvx Incontinence Ring | Deschutes Medical Products, Inc. | 1998 | — |
| +1 | K993308 | Mentor Evacare Vaginal Pessaries | Mentor Corp. | 1999 | — |
| +2 | K253698 | Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with… | Cooper Surgical | 2026 | — |
| +2 | K250438 | CooperSurgical Milex® Pessaries | CooperSurgical, Inc. | 2025 | — |
| +1 | K231786 | Gynethotics™ Pessary | Cosm Medical | 2024 | — |
| +1 | K020512 | Mti ST#1 Silicone Pessary | Medical Technology and Innovations, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
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?
- Of its descendants, K993308 (Mentor Corp., 1999) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HHW devicesHHW Pessary, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 PelvX Incontinence Ring Vaginal Pessary is a vaginal pessary intended for treatment of @& urinary incontinence.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974116 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974116: Pelvx Incontinence Ring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974116
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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