Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Classys, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253504 | Volnewmer™ | Classys, Inc. | 2026-07-13 | 255 | 0 |
| K253123 | CuRAS hybrid | Classys, Inc. | 2025-11-20 | 56 | 0 |
| K240248 | Volnewmer™ | Classys, Inc. | 2024-04-29 | 90 | 0 |
| K230100 | SCIZER (SC1-M410) | Classys, Inc. | 2023-11-03 | 294 | 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