Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QXQ — Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252471 | Paptizer 360 | LiViliti Health Products Corporation | 2026-04-29 | 266 | 0 |
| K243815 | SoClean 3+ | Soclean, Inc. | 2025-10-10 | 303 | 0 |
| DEN210037 | SoClean 3+ Bacterial Reduction Device | Soclean, Inc. | 2024-08-12 | 1062 | 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