Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mallinckrodt Manufacturing, LLC · 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) |
|---|---|---|---|---|---|
| K242578 | EVOLVE Nitric Oxide Delivery System | Mallinckrodt Manufacturing, LLC | 2025-01-03 | 127 | 0 |
| K222930 | Evolve Nitric Oxide Delivery System | Mallinckrodt Manufacturing, LLC | 2023-12-06 | 436 | 0 |
| K211153 | Inomax DSIR | Mallinckrodt Manufacturing, LLC | 2023-04-20 | 731 | 0 |
| K200389 | INOmax DSIR Plus | Mallinckrodt Manufacturing, LLC | 2020-06-17 | 120 | 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