510(k) · Cleared
ClearedTIPI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contipi, Ltd. · HHW Pessary, Vaginal
Cleared on Jun 9, 2006 as substantially equivalent to K930618 (Johnson & Johnson Medical, Inc., 1995) and 1 other predicate after a 102-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- Jun 9, 2006
- Review
- 102 days
- Class
- Class II
- Product code
- HHW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930618 (1995). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK930618 Vaginal Continence DeviceJohnson & Johnson Medical, Inc. · 1995
- This deviceK060526 TIPIContipi, Ltd. · 2006
- Descendant · cites it directly · 2 of its ownK131198 Tipi OtcContipi, Ltd. · 2013
- Descendant · 2 generations on · 1 of its ownK151413 Always/Tampax bladder supportsProcter & Gamble · 2015
- Descendant · 3 generations on · 0 of its ownK183468 Revive Reusable Bladder SupportRinovum Subsidiary 2, LLC · 2019 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930618 | Vaginal Continence Device | Johnson & Johnson Medical, Inc. | 1995 | — |
| 0 (this device) | K060526 | TIPI | Contipi, Ltd. | 2006 | — |
| +1 | K131198 | Tipi Otc | Contipi, Ltd. | 2013 | — |
| +2 | K151413 | Always/Tampax bladder supports | Procter & Gamble | 2015 | — |
| +3 | K183468 | Revive Reusable Bladder Support | Rinovum Subsidiary 2, LLC | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K930618 | Vaginal Continence DeviceSummary page 1…Name - Vaginal pessary Device -- Predicate Devices -- Johnson & Johnson - Introl ®- Bladder Neck Support K930618 and K965040 Device Description - a device which is placed intra-vaginally to provide mid-urethral support. The so… | 1995 |
| * | K965040 | Introl Bladder Neck Support Prosthesis with Removal ToolSummary page 1…Vaginal pessary Device -- Predicate Devices -- Johnson & Johnson - Introl ®- Bladder Neck Support K930618 and K965040 Device Description - a device which is placed intra-vaginally to provide mid-urethral support. The soft, flexible… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131198 | Tipi Otc | 2013 | 2 |
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.
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?
Vaginal Pessary device is indicated for temporary management of genuine (mild, moderate, and severe) stress urinary incontinence in females.
Vaginal Pessary device is designed to be used by any woman, who suffers from stress urinary incontinence.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060526 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060526: TIPI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060526
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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