510(k) · Cleared
ClearedCooperSurgical Milex® Pessaries
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperSurgical, Inc. · HHW Pessary, Vaginal
Cleared on Apr 11, 2025 as substantially equivalent to K993308 (Mentor Corp., 1999) after a 56-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Apr 11, 2025
- Review
- 56 days
- Class
- Class II
- Product code
- HHW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K904026 (1990). 7 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904026 | Inflat-O-Ball | Milex Products, Inc. | 1990 | 13 |
| −1 | K993308 | Mentor Evacare Vaginal Pessaries | Mentor Corp. | 1999 | — |
| 0 (this device) | 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 |
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.
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 35 years and passes through 3 companies; a new generation was cleared every 25.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K993308.
How does its category compare?
All HHW devicesHHW Pessary, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 CooperSurgical Milex pessaries are intended to provide support to pelvic organs when inserted in the vagina. The following Indications for Use are associated with each of the following pessary styles: Milex® Shaatz Folding Pessaries: Shaatz pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage I and Stage II prolapse, complicated by a mild cystocele. Milex® Gellhorn Pessaries: Gellhorn pessary is indicated for…
Read the full statement (114 words)
The CooperSurgical Milex pessaries are intended to provide support to pelvic organs when inserted in the vagina.
The following Indications for Use are associated with each of the following pessary styles:
Milex® Shaatz Folding Pessaries:
Shaatz pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage I and Stage II prolapse, complicated by a mild cystocele.
Milex® Gellhorn Pessaries:
Gellhorn pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage III prolapse or procidentia.
Milex® Ring Folding Pessaries:
Milex Ring Pessary is indicated for use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250438: CooperSurgical Milex® Pessaries.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250438
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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