Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Weero Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
182 daysmedian FDA review time
379 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253542 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026-06-08 | 206 | 0 |
| K253261 | Apollo Quattro (APQ-10M) | Weero Co., Ltd. | 2026-03-13 | 165 | 0 |
| K241433 | EVE Synergy (EVE-20M) | Weero Co., Ltd. | 2025-06-04 | 379 | 0 |
| K240992 | eMVFit (MVF-10M) | Weero Co., Ltd. | 2024-10-10 | 182 | 0 |
| K240991 | eMVFit (MVF-10M) | Weero Co., Ltd. | 2024-10-09 | 181 | 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