Dymax Corp: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Dymax Corp” (first 1985, latest 2003), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 71 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 4 | 4 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| HGL | Transducer, Ultrasonic, Obstetric | 1 | 1 |
Review panels
- Radiology (4)
- Cardiovascular (2)
- Obstetrics and Gynecology (1)
Most recent Dymax Corp 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032135 | SITE-RITE IV ULTRASOUND SYSTEM | IYO | 2003-07-21 | 10 |
| K993624 | SITE-RITE 3 ULTRASOUND SYSTEM | IYO | 1999-11-10 | 15 |
| K931403 | SITERITE NEEDLE GUIDE (MODIFIED) | DQY | 1993-07-27 | 130 |
| K903158 | SITERITE NEEDLE GUIDE | DQY | 1990-09-27 | 71 |
| K894415 | DYMAX ENDOVAGINAL BIOPSY GUIDE | HGL | 1989-10-25 | 100 |
| K862127 | DYMAX PERSONAL SCANNER | IYO | 1986-12-11 | 190 |
| K850478 | PLUS 1 | IYO | 1985-04-15 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named Dymax Corp.
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 Dymax Corp?
FDA lists 7 510(k) clearances under the applicant name “Dymax Corp” (first 1985, latest 2003), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dymax Corp?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dymax Corp is 71 days.
Which FDA product codes appear under Dymax Corp?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 4); DQY (Catheter, Percutaneous, 2); HGL (Transducer, Ultrasonic, Obstetric, 1).
Next steps
- See all 7 Dymax Corp clearances with predicates and recalls
- Run predicate analysis for product code IYO, Dymax Corp'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.