510(k) · Cleared
ClearedPanpac Vaginal Pessary
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Panpac Medical Corporation · HHW Pessary, Vaginal
Cleared on Jul 22, 2010 after a 297-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jul 22, 2010
- Review
- 297 days
- Class
- Class II
- Product code
- HHW
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK092981 Panpac Vaginal PessaryPanpac Medical Corporation · 2010
- Descendant · cites it directly · 3 of its ownK132313 PessaryEis Corporation · 2014
- Descendant · 2 generations on · 1 of its ownK190277 ProVate Vaginal SupportContipi Medical, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK253698 Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish…Cooper Surgical · 2026
- Descendant · 3 generations on · 0 of its ownK232677 Reia pessaryReia, LLC · 2024
- Descendant · cites it directly · 0 of its ownK231786 Gynethotics™ PessaryCosm Medical · 2024
Most influential descendants
Showing 5 of 5 · See all- K132313PessaryEis Corporation · 2014 · cites it directly3descendants
- K190277ProVate Vaginal SupportContipi Medical, Ltd. · 2019 · 2 generations on1descendant
- K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support…Cooper Surgical · 2026 · 2 generations on0descendants
- K232677Reia pessaryReia, LLC · 2024 · 3 generations on0descendants
- K231786Gynethotics™ PessaryCosm Medical · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092981 | Panpac Vaginal Pessary | Panpac Medical Corporation | 2010 | — |
| +1 | K132313 | Pessary | Eis Corporation | 2014 | — |
| +2 | K190277 | ProVate Vaginal Support | Contipi Medical, Ltd. | 2019 | — |
| +2 | K253698 | Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with… | Cooper Surgical | 2026 | — |
| +3 | K232677 | Reia pessary | Reia, LLC | 2024 | — |
| +1 | K231786 | Gynethotics™ Pessary | Cosm Medical | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 2 | 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)
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?
- Of its descendants, K132313 (Eis Corporation, 2014) has gone furthest, with 3 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. 2010, 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?
Panpac Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele, rectocele as well as stress urinary incontinence in women.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K092981 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092981: Panpac Vaginal Pessary.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092981
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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