510(k) · Cleared
ClearedMentor Evacare Vaginal Pessaries
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentor Corp. · HHW Pessary, Vaginal
Cleared on Dec 13, 1999 as substantially equivalent to K904026 (Milex Products, Inc., 1990) and 5 other predicates after a 70-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.
- Decided
- Dec 13, 1999
- Review
- 70 days
- Class
- Class II
- Product code
- HHW
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 1 generation to K904026 (1990). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK904026 Inflat-O-BallMilex Products, Inc. · 1990 · Recalled
- This deviceK993308 Mentor Evacare Vaginal PessariesMentor Corp. · 1999
- Descendant · cites it directly · 0 of its ownK253698 Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish…Cooper Surgical · 2026
- Descendant · cites it directly · 0 of its ownK250438 CooperSurgical Milex® PessariesCooperSurgical, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904026 | Inflat-O-Ball | Milex Products, Inc. | 1990 | 13 |
| 0 (this device) | K993308 | Mentor Evacare Vaginal Pessaries | Mentor Corp. | 1999 | — |
| +1 | K253698 | Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with… | Cooper Surgical | 2026 | — |
| +1 | K250438 | CooperSurgical Milex® Pessaries | CooperSurgical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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? (6)
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 |
|---|---|---|---|
| * | K904026 | Inflat-O-BallSummary page 2…ntial Equivalence Claim: Mentor EvaCare™ Vaginal Pessaries are substantially equivalent to pre- amendment devices and pessaries manufactured by: e Milex Products, Inc. K904026 Inflat-o-Ball ¢ DesChutes Medical Products, Inc. K974117 Pelvx Donut, Pelvx Cube K974116 Pelvx Incontinence Ring K974115 Pelvx… | 1990 |
| * | K974117 | Pelvx Donut, Pelvx CubeSummary page 2…s are substantially equivalent to pre- amendment devices and pessaries manufactured by: e Milex Products, Inc. K904026 Inflat-o-Ball ¢ DesChutes Medical Products, Inc. K974117 Pelvx Donut, Pelvx Cube K974116 Pelvx Incontinence Ring K974115 Pelvx Ring, Pelvx Ring with Support e Bioteque America, Inc. K… | 1998 |
| * | K974116 | Pelvx Incontinence RingSummary page 2…pre- amendment devices and pessaries manufactured by: e Milex Products, Inc. K904026 Inflat-o-Ball ¢ DesChutes Medical Products, Inc. K974117 Pelvx Donut, Pelvx Cube K974116 Pelvx Incontinence Ring K974115 Pelvx Ring, Pelvx Ring with Support e Bioteque America, Inc. K920747 Pessary Flexible Silicone… | 1998 |
| * | K974115 | Pelvx Ring, Pelvx Ring with SupportSummary page 2…aries manufactured by: e Milex Products, Inc. K904026 Inflat-o-Ball ¢ DesChutes Medical Products, Inc. K974117 Pelvx Donut, Pelvx Cube K974116 Pelvx Incontinence Ring K974115 Pelvx Ring, Pelvx Ring with Support e Bioteque America, Inc. K920747 Pessary Flexible Silicone Donut Ring K920187 Flexible Sili… | 1998 |
| * | K920747 | Pessary Flexible Silicone Donut RingSummary page 2…DesChutes Medical Products, Inc. K974117 Pelvx Donut, Pelvx Cube K974116 Pelvx Incontinence Ring K974115 Pelvx Ring, Pelvx Ring with Support e Bioteque America, Inc. K920747 Pessary Flexible Silicone Donut Ring K920187 Flexible Silicone Gellhorn Device Description: Mentor EvaCare™ Vaginal Pessaries a… | 1994 |
| * | K920187 | Flexible Silicone GelihornSummary page 2…lvx Donut, Pelvx Cube K974116 Pelvx Incontinence Ring K974115 Pelvx Ring, Pelvx Ring with Support e Bioteque America, Inc. K920747 Pessary Flexible Silicone Donut Ring K920187 Flexible Silicone Gellhorn Device Description: Mentor EvaCare™ Vaginal Pessaries are manufactured from medical grade silicone e… | 1992 |
What descends from it? (2)
2 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?
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K253698 (Cooper Surgical, 2026) has gone furthest, with 0 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?
A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse. Please refer to the attached page for a listing of indications for use for each pessary style. Donut Pessary: Support of third degree prolapse, cystocele and rectocele. Ring Pessary: Support of first or second degree prolapse. Ring with support can also be used on an accompanying cystocele. Dish Pessary…
Read the full statement (198 words)
A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse.
Please refer to the attached page for a listing of indications for use for each pessary style.
Donut Pessary: Support of third degree prolapse, cystocele and rectocele.
Ring Pessary: Support of first or second degree prolapse. Ring with support can also be used on an accompanying cystocele.
Dish Pessary: Control of stress urinary incontinence and support of minor degrees of prolapse.
Oval Pessary: Support of first or second degree prolapse and accompanying cystocyle.
Shaatz Pessary: Support of first or second degree prolapse and accompanying cystocyle.
Mar-Land Pessary: Control of stress urinary incontinence and support of minor degrees of prolapse.
Hodge Pessary: Support of first to second degree prolapse, a cystocele, stress urinary incontinence and an incompetent cervix or uterine retroversion..
Gehrung Pessary: Support of cystocele and rectocele, as well as support of second to third degree prolapse.
Gellhorn Pessary: Support of second to third degree prolapse or procidentia.
Cube Pessary: Support of third degree prolapse, procidentia, cystocele, and rectocele.
Fitting Set: Used to determine the proper size of pessary for each patient.
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/K993308 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993308: Mentor Evacare Vaginal Pessaries.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993308
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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