510(k) · Cleared
Clearedin2 Smart (in2S)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Virility Medical, Ltd. · QRC Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation
Cleared on Apr 6, 2026 as substantially equivalent to K223595 (Virility Medical, Ltd., 2023) after a 215-day review. Its family tree reaches back 2 generations to 2021.
- Decided
- Apr 6, 2026
- Review
- 215 days
- Class
- Class II
- Product code
- QRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN210012 (2021). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 QRC? 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 QRC device
- #1 K223595 vPATCHscore 11.3 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K223595 | vPATCHSummary page 6…Predicate Device Iden fica on: The in2 Smart is substan ally equivalent to the following primary predicate: vPATCH, manufactured by Virility Medical Ltd., 510(k) Number: K223595; Product Code: QRC. This predicate device has not been subject to a design-related recall. Device Descrip on: The in2 Smart de… | 2023 |
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 5 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K223595.
How does its category compare?
All QRC devicesQRC Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QRC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QRC
Too few QRC 510(k)s in any year since 2007 to give a median.
Recalls per year · QRC
No recall names QRC since 2007.
Adverse event reports per year · QRC
No MAUDE report names QRC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The in2 Smart is indicated for management of premature ejaculation in males who ejaculate after intromission. It is designed to increase the time between arousal and ejaculation by delivery of short duration, low-intensity electrical stimulation to the perineal muscles and nerves during intercourse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252809 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252809: in2 Smart (in2S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252809
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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