Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Paul Hartmann Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
50 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K843404 | MOLINEA INCONTINENT PAD | Paul Hartmann Corp. | 1984-10-19 | 50 | 0 |
| K843405 | MOLICARE | Paul Hartmann Corp. | 1984-10-19 | 50 | 0 |
| K843403 | MOLINEA PANTY | Paul Hartmann Corp. | 1984-10-19 | 50 | 0 |
| K843401 | RIA PANTY SHIELDS | Paul Hartmann Corp. | 1984-10-15 | 46 | 0 |
| K843402 | MOLINEA UNDERPADS | Paul Hartmann Corp. | 1984-09-07 | 8 | 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