Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Marcal Paper Mills, 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) |
|---|---|---|---|---|---|
| K901690 | WHENEVER(R) UNSCENTED SUPER MAXI PAD | Marcal Paper Mills, Inc. | 1990-08-21 | 133 | 0 |
| K861357 | WHENEVER UNSCENTED PANTY SHIELD | Marcal Paper Mills, Inc. | 1986-04-23 | 13 | 0 |
| K861356 | WHENEVER UNSCENTED SUPER THIN MAXI-PADS | Marcal Paper Mills, Inc. | 1986-04-23 | 13 | 0 |
| K861355 | WHENEVER UNSCENTED REGULAR THIN MAXI-PADS | Marcal Paper Mills, Inc. | 1986-04-23 | 13 | 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