Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Unimom.Co · 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) |
|---|---|---|---|---|---|
| K242111 | VIVACE | Unimom.Co | 2025-02-06 | 202 | 0 |
| K232047 | VIVACE | Unimom.Co | 2024-03-28 | 262 | 0 |
| K190810 | OPERA, OPERA eco | Unimom.Co | 2019-08-30 | 154 | 0 |
| K180075 | MINUET LCD, MINUET LCD eco | Unimom.Co | 2018-08-06 | 208 | 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