Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medix Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
745 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921273 | EASIMIST ULTRASONIC NEBULIZER | Medix Corp. | 1994-04-01 | 745 | 0 |
| K914772 | MEDIX NEBULIZING SYSTEM CODE NO. 2000 AND 2001 | Medix Corp. | 1992-07-24 | 312 | 0 |
| K853071 | MEDIX ELECTRONIC NEBULIZING SYSTEM | Medix Corp. | 1985-08-29 | 37 | 0 |
| K822454 | SYRINGE PUMP 209-100 | Medix Corp. | 1982-10-18 | 63 | 0 |
| K780444 | NERVTRON-RX | Medix Corp. | 1978-04-19 | 30 | 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