510(k) · Cleared
ClearedPessary
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eis Corporation · HHW Pessary, Vaginal
Cleared on Dec 5, 2014 as substantially equivalent to K092981 (Panpac Medical Corporation, 2010) after a 498-day review. Its family tree reaches back 1 generation to 2010. 3 later devices descend from it.
- Decided
- Dec 5, 2014
- Review
- 498 days
- Class
- Class II
- Product code
- HHW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K092981 (2010). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK092981 Panpac Vaginal PessaryPanpac Medical Corporation · 2010
- This deviceK132313 PessaryEis Corporation · 2014
- Descendant · cites it directly · 1 of its ownK190277 ProVate Vaginal SupportContipi Medical, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK253698 Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish…Cooper Surgical · 2026
- Descendant · 2 generations on · 0 of its ownK232677 Reia pessaryReia, LLC · 2024
Most influential descendants
Showing 3 of 3 · See all- K190277ProVate Vaginal SupportContipi Medical, Ltd. · 2019 · cites it directly1descendant
- K253698Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with Support…Cooper Surgical · 2026 · cites it directly0descendants
- K232677Reia pessaryReia, LLC · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K092981 | Panpac Vaginal Pessary | Panpac Medical Corporation | 2010 | — |
| 0 (this device) | K132313 | Pessary | Eis Corporation | 2014 | — |
| +1 | K190277 | ProVate Vaginal Support | Contipi Medical, Ltd. | 2019 | — |
| +1 | K253698 | Milex™ Incontinence Dish Pessaries; Milex™ Incontinence Dish Pessaries with… | Cooper Surgical | 2026 | — |
| +2 | K232677 | Reia pessary | Reia, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K092981 | Panpac Vaginal PessarySummary page 4…nal pessary Panel: Obstetrics/Gynecology Product code: HHW Regulation: 21 CFR 884.3575 Predicate Device Information: K092981 / PANPAC VAGINAL PESSARY (Panpac Medical Corporation) Device Description: The subject device is a silicone vaginal pessary. The… | 2010 |
What descends from it? (3)
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?
How does its category compare?
All HHW devicesHHW Pessary, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
EIS Vaginal Pessaries are indicated for the 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/K132313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132313: Pessary.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132313
Report an extraction error
Are you the manufacturer?
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