Virility Medical , Ltd.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Virility Medical , Ltd.” (first 2023, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 182 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2023 | 1 | 150 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 215 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Virility Medical , Ltd. took a median 182 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 215 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QRC | Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation | 3 | 2 |
Review panels
Most recent Virility Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252809 | in2 Smart (in2S) | QRC | 2026-04-06 | 215 |
| K223595 | vPATCH | QRC | 2023-05-01 | 150 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210012 | De Novo | Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation | 2021-11-23 |
Recalls
openFDA lists no recalls under a recalling firm named Virility Medical , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Virility Medical , Ltd. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03942367: Evaluation of the Safety and Effectiveness of the vPatch Device (Completed, started 2019-09-10)
- NCT03174470: Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle (Completed, started 2016-11-02)
Frequently asked questions
How many FDA 510(k) clearances are listed under Virility Medical , Ltd.?
FDA lists 2 510(k) clearances under the applicant name “Virility Medical , Ltd.” (first 2023, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Virility Medical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Virility Medical , Ltd. is 182 days.
Which FDA product codes appear under Virility Medical , Ltd.?
The most frequent FDA product codes under this applicant name are QRC (Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation, 3).
Next steps
- See all 2 Virility Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QRC, Virility Medical , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.