510(k) · Cleared
ClearedAlways/Tampax bladder supports
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Procter & Gamble · HHW Pessary, Vaginal
Cleared on Dec 18, 2015 as substantially equivalent to K131198 (Contipi, Ltd., 2013) after a 205-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Dec 18, 2015
- Review
- 205 days
- Class
- Class II
- Product code
- HHW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930618 (1995). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK930618 Vaginal Continence DeviceJohnson & Johnson Medical, Inc. · 1995
- 2 generations backK060526 TIPIContipi, Ltd. · 2006
- 1 generation backK131198 Tipi OtcContipi, Ltd. · 2013
- This deviceK151413 Always/Tampax bladder supportsProcter & Gamble · 2015
- Descendant · cites it directly · 0 of its ownK183468 Revive Reusable Bladder SupportRinovum Subsidiary 2, LLC · 2019 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K183468Revive Reusable Bladder SupportRinovum Subsidiary 2, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930618 | Vaginal Continence Device | Johnson & Johnson Medical, Inc. | 1995 | — |
| −2 | K060526 | TIPI | Contipi, Ltd. | 2006 | — |
| −1 | K131198 | Tipi Otc | Contipi, Ltd. | 2013 | — |
| 0 (this device) | K151413 | Always/Tampax bladder supports | Procter & Gamble | 2015 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K131198 | Tipi OtcSummary page 4…upports Indications for Use/ Intended Use For the temporary management of stress urinary incontinence (SUI) in women Predicate Device Improve Bladder Supports/TIPI OTC K131198; Manufactured by ConTIPI Ltd. Device Description The device is a single use vaginal pessary, inserted into the vagina, by the us… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183468 | Revive Reusable Bladder Support | 2019 | 0 |
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 20 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K183468 (Rinovum Subsidiary 2, LLC, 2019) has gone furthest, with 0 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. 2015, 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?
For the temporary management of stress urinary incontinence in women
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151413 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151413: Always/Tampax bladder supports.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151413
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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