Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
VIOL Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
191 daysmedian FDA review time
239 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240897 | Cellinew | VIOL Co., Ltd. | 2024-11-26 | 239 | 0 |
| K213612 | SYLFIRM X | VIOL Co., Ltd. | 2022-06-23 | 220 | 0 |
| K200185 | SYLFIRM X | VIOL Co., Ltd. | 2020-04-22 | 89 | 0 |
| K180872 | SCARLET SRF | VIOL Co., Ltd. | 2018-10-11 | 191 | 0 |
| K172023 | CELFIRM | VIOL Co., Ltd. | 2017-10-13 | 100 | 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