Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mason-Keller Corp. — 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) |
|---|---|---|---|---|---|
| K940409 | M-K HYDROGEL DRESSING | Mason-Keller Corp. | 1994-07-11 | 165 | 0 |
| K940035 | KIT,I.V. START | Mason-Keller Corp. | 1994-06-03 | 150 | 0 |
| K940110 | M-K WET SALINE DRESSING | Mason-Keller Corp. | 1994-03-22 | 71 | 0 |
| K940069 | DRESSING CHANGE KIT | Mason-Keller Corp. | 1994-03-18 | 71 | 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