Pro-Tronics, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Pro-Tronics, Inc.” (first 1989, latest 1995), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 59 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 |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | 4 | 4 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
Review panels
- Radiology (5)
Most recent Pro-Tronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950971 | MOBIL C-ARM, REGURBISHED, VARIOUS MODELS | JAA | 1995-04-11 | 49 |
| K944442 | GENERAL ELECTRIC AMX 110, AMX II AND AMX 3 | IZL | 1995-03-14 | 183 |
| K902610 | GENERAL ELECTRIC AMX 3 | IZL | 1990-07-02 | 20 |
| K891143 | GENERAL ELECTRIC AMX 110 | IZL | 1989-05-03 | 61 |
| K891142 | GENERAL ELECTRIC AMX II | IZL | 1989-05-01 | 59 |
Recalls
openFDA lists no recalls under a recalling firm named Pro-Tronics, 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 Pro-Tronics, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Pro-Tronics, Inc.” (first 1989, latest 1995), 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 Pro-Tronics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pro-Tronics, Inc. is 59 days.
Which FDA product codes appear under Pro-Tronics, Inc.?
The most frequent FDA product codes under this applicant name are IZL (System, X-Ray, Mobile, 4); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 1).
Next steps
- See all 5 Pro-Tronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IZL, Pro-Tronics, 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.