510(k) · Cleared
ClearedCntrl+ Bladder Support Pessary
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cntrl+, Inc. · HHW Pessary, Vaginal
Cleared on Dec 17, 2024 as substantially equivalent to K081385 (Eastmed, Inc., 2008) after a 270-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Dec 17, 2024
- Review
- 270 days
- Class
- Class II
- Product code
- HHW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930618 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930618 | Vaginal Continence Device | Johnson & Johnson Medical, Inc. | 1995 | — |
| −1 | K081385 | Uresta Pessary | Eastmed, Inc. | 2008 | — |
| 0 (this device) | K240798 | Cntrl+ Bladder Support Pessary | Cntrl+, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 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 |
|---|---|---|---|
| * | K081385 | Uresta PessarySummary page 5…HHW Panel: Gastroenterology/Urology 3. PREDICATE DEVICE IDENTIFICATION Uresta™ Pessary (K081385) Predicate device was not subjected to any design related recall. 4. DEVICE DESCRIPTION: The subject Pessary is design… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 3 companies; a new generation was cleared every 16.2 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K081385.
How does its category compare?
All HHW devicesHHW Pessary, Vaginal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The Cntrl+ Bladder Support Pessary is intended for the use in adult women, over 18 years of age who experience involuntary urine loss with physical activity (stress urinary incontinence).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240798 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240798: Cntrl+ Bladder Support Pessary.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240798
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