Med-Tron Products, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Med-Tron Products, Inc.” (first 1990, latest 1995), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| IYZ | Bed, Scanning, Nuclear | 6 | 6 |
| IYX | Camera, Scintillation (Gamma) | 2 | 2 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 1 | 1 |
Review panels
- Radiology (9)
Most recent Med-Tron Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952701 | MED-TRON SPECT IMAGING TABLE | IZZ | 1995-07-06 | 23 |
| K911691 | XYZ CRANK IMAGING TABLE | IYZ | 1991-08-09 | 115 |
| K912181 | E-Z LIFT CRANK IMAGING TABLE | IYZ | 1991-07-17 | 62 |
| K912135 | XY IMAGING TABLE | IYZ | 1991-07-17 | 64 |
| K911564 | E-Z LIFT IMAGING TABLE WITH FOOT PUMP | IYZ | 1991-07-15 | 97 |
| K911561 | XYZ IMAGING TABLE WITH FOOT PUMP | IYZ | 1991-07-15 | 97 |
| K905827 | FULL VIEW OMEGA TABLE | IYX | 1991-01-28 | 28 |
| K903988 | PANORAMIC OMEGA IMAGING TABLE | IYX | 1990-10-23 | 55 |
| K903901 | SCANNING COT | IYZ | 1990-09-21 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Med-Tron Products, 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 Med-Tron Products, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Med-Tron Products, Inc.” (first 1990, latest 1995), across 3 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 Med-Tron Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Med-Tron Products, Inc. is 62 days.
Which FDA product codes appear under Med-Tron Products, Inc.?
The most frequent FDA product codes under this applicant name are IYZ (Bed, Scanning, Nuclear, 6); IYX (Camera, Scintillation (Gamma), 2); IZZ (Table, Radiographic, Non-Tilting, Powered, 1).
Next steps
- See all 9 Med-Tron Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYZ, Med-Tron Products, 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.