Medtrax Industries, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Medtrax Industries, Inc.” (first 1993, latest 1994), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 50 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 5 | 5 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
Review panels
Most recent Medtrax Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940692 | PLAIN GAUZE DRESSING | EFQ | 1994-04-14 | 57 |
| K940691 | WET DRESSING | FRO | 1994-03-31 | 43 |
| K940694 | XEROFORM PETROLATUM DRESSING | FRO | 1994-03-30 | 42 |
| K940693 | PETROLATUM DRESSING | FRO | 1994-03-30 | 42 |
| K933966 | SURE-ADAPT NON-ADHERING DRESSING | FRO | 1993-10-28 | 73 |
| K926207 | MEDTRAX PACKING STRIP | FRO | 1993-05-12 | 154 |
Recalls
openFDA lists no recalls under a recalling firm named Medtrax Industries, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtrax Industries, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Medtrax Industries, Inc.” (first 1993, latest 1994), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medtrax Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtrax Industries, Inc. is 50 days.
Which FDA product codes appear under Medtrax Industries, Inc.?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 5); EFQ (Gauze/Sponge, Internal, 1).
Next steps
- See all 6 Medtrax Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Medtrax Industries, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.