510(k) · Cleared
ClearedMarina Medical Silicone Pessary
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marina Medical Instruments, Inc. · HHW Pessary, Vaginal
Cleared on Nov 18, 2003 as substantially equivalent to K013289 (Bioteque America, Inc., 2001) after a 194-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Nov 18, 2003
- Review
- 194 days
- Class
- Class II
- Product code
- HHW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013289 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK013289 Bioteque Vaginal PessariesBioteque America, Inc. · 2001
- This deviceK031463 Marina Medical Silicone PessaryMarina Medical Instruments, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013289 | Bioteque Vaginal Pessaries | Bioteque America, Inc. | 2001 | — |
| 0 (this device) | K031463 | Marina Medical Silicone Pessary | Marina Medical Instruments, Inc. | 2003 | — |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013289 | Bioteque Vaginal Pessaries | 2001 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K013289.
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?
This device is made out of silicone, and it is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia. It is available with different sizes of the following models: CUBE (with and without drain), OVAL (with and without support), HODGE (with and without support), SHAATZ, GELLHORN (with and…
Read the full statement (247 words)
This device is made out of silicone, and it is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia. It is available with different sizes of the following models: CUBE (with and without drain), OVAL (with and without support), HODGE (with and without support), SHAATZ, GELLHORN (with and without drains), RING (with and without support), DONUT, GEHRUNG, DISH (with and without support), & MAR-LAND (with and without support).
CUBE: indicated for use for the support of a third-degree prolapse.
OVAL: indicated for use for the support of a first or mild second-degree prolapse.
HODGE: indicated for use for the support of a uterine retroversion.
SHAATZ: indicated for use for the support of a first or mild second-degree prolapse.
GELLHORN: indicated for use for the support of a third-degree prolapse or procidentia.
RING: indicated for use for the support of a first or mild second-degree prolapse.
DONUT: indicated for use for the support of a third-degree prolapse.
GEHRUNG: indicated for use for the support of cystocele or rectocele.
DISH: indicated for use for the control of stress urinary incontinence or a first or mild second-degree prolapse. It restores continence by applying gentle pressure to the urethra.
MAR-LAND: indicated for use for the control of stress urinary incontinence or a first or mild second-degree prolapse. It restores continence by applying gentle pressure tQ the uretftrr
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031463 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031463: Marina Medical Silicone Pessary.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031463
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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