Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Molnlycke A/S Hospital Products · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861250 | MESULIN, INSULIN INFUSION SET | Molnlycke A/S Hospital Products | 1986-05-23 | 51 | 0 |
| K843539 | TELEDYNE DENSCO DRY TIPS SALIVA ABSORB- | Molnlycke A/S Hospital Products | 1985-05-23 | 258 | 0 |
| K833398 | MESULIN INSULIN INFUSION SET | Molnlycke A/S Hospital Products | 1984-03-06 | 158 | 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