Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QRC — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252809 | in2 Smart (in2S) | Virility Medical , Ltd. | 2026-04-06 | 215 | 0 |
| K241897 | MOR | Morari, Inc. | 2025-02-11 | 228 | 0 |
| K223595 | vPATCH | Virility Medical , Ltd. | 2023-05-01 | 150 | 0 |
| DEN210012 | vPatch | Virility Medical | 2021-11-23 | 238 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda