Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cui Corp. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
76 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K913140 | SILICONE GEL SHEETING | Cui Corp. | 1991-09-30 | 76 | 0 |
| K904350 | CUI DORSAL COLUMELLA PROSTHESIS | Cui Corp. | 1990-11-26 | 63 | 0 |
| K904349 | CUI CURVILINEAR SILICONE CHIN | Cui Corp. | 1990-11-26 | 63 | 0 |
| K904348 | CUI FEATHERED SILICONE MALAR | Cui Corp. | 1990-11-26 | 63 | 0 |
| K903327 | CUI ARTICULATED SILICONE CHIN | Cui Corp. | 1990-09-10 | 47 | 0 |
| K903328 | CUI PREMAXILLARY IMPLANT | Cui Corp. | 1990-09-10 | 47 | 0 |
| K903329 | CUI ANATOMICAL SILICONE MALAR | Cui Corp. | 1990-09-10 | 47 | 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