510(k) · Cleared
ClearedIntrol Bladder Neck Support Prosthesis with Removal Tool
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Medical, Inc. · HHW Pessary, Vaginal
Cleared on Mar 10, 1997 after an 83-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Mar 10, 1997
- Review
- 83 days
- Class
- Class II
- Product code
- HHW
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK965040 Introl Bladder Neck Support Prosthesis with Removal ToolJohnson & Johnson Medical, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK081385 Uresta PessaryEastmed, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK060526 TIPIContipi, Ltd. · 2006
- Descendant · 2 generations on · 2 of its ownK131198 Tipi OtcContipi, Ltd. · 2013
- Descendant · 3 generations on · 1 of its ownK151413 Always/Tampax bladder supportsProcter & Gamble · 2015
- Descendant · 2 generations on · 1 of its ownK083769 Modification to Uresta PessaryEastmed, Inc. · 2009
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K081385Uresta PessaryEastmed, Inc. · 2008 · cites it directly4descendants
- K060526TIPIContipi, Ltd. · 2006 · cites it directly3descendants
- K131198Tipi OtcContipi, Ltd. · 2013 · 2 generations on2descendants
- K151413Always/Tampax bladder supportsProcter & Gamble · 2015 · 3 generations on1descendant
- K083769Modification to Uresta PessaryEastmed, Inc. · 2009 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K965040 | Introl Bladder Neck Support Prosthesis with Removal Tool | Johnson & Johnson Medical, Inc. | 1997 | — |
| +1 | K081385 | Uresta Pessary | Eastmed, Inc. | 2008 | — |
| +1 | K060526 | TIPI | Contipi, Ltd. | 2006 | — |
| +2 | K131198 | Tipi Otc | Contipi, Ltd. | 2013 | — |
| +3 | K151413 | Always/Tampax bladder supports | Procter & Gamble | 2015 | — |
| +2 | K083769 | Modification to Uresta Pessary | Eastmed, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 3 | 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 |
|---|---|---|---|
| * | — | INTROL Bladder Neck Support Prosthesis Named without a submission number |
What descends from it? (9)
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, K081385 (Eastmed, Inc., 2008) has gone furthest, with 4 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.
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?
The INTROL* Bladder Neck Support Prosthesis with Removal Tool is indicated for the temporary management of genuine stress urinary incontinence.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965040 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965040: Introl Bladder Neck Support Prosthesis with Removal Tool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965040
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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