Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vts, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
88 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012662 | SE-100 VACUUM ERECTION DEVICE | Vts, Inc. | 2001-11-09 | 88 | 0 |
| K012619 | VT-1 | Vts, Inc. | 2001-11-09 | 88 | 0 |
| K012639 | SE-300 VACUUM THERAPY SYSTEM | Vts, Inc. | 2001-11-09 | 88 | 0 |
| K012620 | SE-200 | Vts, Inc. | 2001-11-09 | 88 | 0 |
| K992442 | V.T.S., INC. (V.T.-3) | Vts, Inc. | 1999-10-05 | 75 | 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