Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtrax Industries, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
154 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K940692 | PLAIN GAUZE DRESSING | Medtrax Industries, Inc. | 1994-04-14 | 57 | 0 |
| K940691 | WET DRESSING | Medtrax Industries, Inc. | 1994-03-31 | 43 | 0 |
| K940694 | XEROFORM PETROLATUM DRESSING | Medtrax Industries, Inc. | 1994-03-30 | 42 | 0 |
| K940693 | PETROLATUM DRESSING | Medtrax Industries, Inc. | 1994-03-30 | 42 | 0 |
| K933966 | SURE-ADAPT NON-ADHERING DRESSING | Medtrax Industries, Inc. | 1993-10-28 | 73 | 0 |
| K926207 | MEDTRAX PACKING STRIP | Medtrax Industries, Inc. | 1993-05-12 | 154 | 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