Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HDW · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140305 | CAYA CONTOURED DIAPHRAGM | Kessel Medintim GmbH | 2014-08-26 | 200 | 0 |
| K080040 | ORTHO ALL-FLEX DIAPHRAGM | Johnson & Johnson Produtos Profissionais Ltda. | 2008-08-25 | 231 | 0 |
| K063223 | MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING D | CooperSurgical, Inc. | 2008-01-23 | 456 | 3 |
| K800162 | ONCE TM | G.D. Searle and Co. | 1980-02-11 | 17 | 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