Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dafoe & Dafoe, Inc. — 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) |
|---|---|---|---|---|---|
| K820960 | MAXI & MINI SHIELDS | Dafoe & Dafoe, Inc. | 1982-05-14 | 38 | 0 |
| K820962 | COTTON SWABS | Dafoe & Dafoe, Inc. | 1982-04-20 | 14 | 0 |
| K820961 | INCONTINENCE PAD OR ADULT DIAPER | Dafoe & Dafoe, Inc. | 1982-04-16 | 10 | 0 |
| K800747 | BELTLESS MAXI, MINI & SUPER MAXI PADS | Dafoe & Dafoe, Inc. | 1980-04-29 | 25 | 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