# K252809: in2 Smart (in2S)

- Pathway: 510(k) (Traditional)
- Applicant: Virility Medical, Ltd.
- Decided: Apr 6, 2026 after 215 days
- Product code: QRC (Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation)
- Device class: 2
- Regulation: 21 CFR 876.5026
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN210012 (2021). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223595: vPATCH, Virility Medical, Ltd. (2023) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K252809
Methodology: https://510kreport.com/methodology