Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Monad Corp. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
241 daysmedian FDA review time
385 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K914441 | MENS 2000-D | Monad Corp. | 1991-12-17 | 78 | 0 |
| K902226 | MY-O-MATIC 5000I | Monad Corp. | 1991-06-06 | 385 | 0 |
| K904235 | MENS-O-MATIC 2000 | Monad Corp. | 1991-05-13 | 250 | 0 |
| K904260 | MENS-O-MATIC 3000 | Monad Corp. | 1991-05-13 | 241 | 0 |
| K904234 | MENS-O-MATIC I | Monad Corp. | 1991-05-13 | 248 | 0 |
| K904258 | MICRO DERM | Monad Corp. | 1991-05-13 | 241 | 0 |
| K904288 | MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS | Monad Corp. | 1991-05-13 | 236 | 0 |
| K904430 | MENS FREEDOM MICRO | Monad Corp. | 1991-05-13 | 250 | 0 |
| K891871 | PHASER (SINGLE LINEAR MECHANICAL MASSAGE) | Monad Corp. | 1989-04-25 | 29 | 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