Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eagle Twe, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
94 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051273 | DIVAS DUAL PLEASURE MALE LATEX CONDOM | Eagle Twe, Inc. | 2005-08-19 | 94 | 0 |
| K010028 | SHEER THIN AROMAS RED LATEX CONDOM | Eagle Twe, Inc. | 2001-03-30 | 86 | 0 |
| K004051 | SHEER THIN AROMAS YELLOW LATEX CONDOM | Eagle Twe, Inc. | 2001-03-29 | 90 | 0 |
| K004036 | SHEER THIN AROMAS GREEN LATEX CONDOM | Eagle Twe, Inc. | 2001-03-27 | 89 | 0 |
| K004016 | SHEER THIN AROMAS BLUE LATEX CONDOM | Eagle Twe, Inc. | 2001-03-27 | 90 | 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