Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QVS — Predicate Candidate Screening
2 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252438 | Explant Express | Applied Medical Technology, Inc. | 2026-02-03 | 186 | 0 |
| DEN220082 | Breast Implant Removal Device (BIRD) | Gaylord Solutions, LLC | 2023-04-20 | 150 | 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