Dyn-A-Med Products: FDA clearances and approvals
Dyn-A-Med Products has 5 FDA 510(k) clearances (first 1980, latest 1984), across 5 product codes in 4 review panels. Median 510(k) review time: 47 days.
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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | 1 | 1 |
| FKK | Clamp, Line | 1 | 1 |
| HHT | Spatula, Cervical, Cytological | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (1)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
- General and Plastic Surgery (1)
Most recent Dyn-A-Med Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K844121 | CLAMP, TUBING, LINE | FKK | 1984-12-17 | 55 |
| K813176 | GEL ELECTRODE | DRX | 1981-12-29 | 47 |
| K811157 | BLADE, TONGUE | — | 1981-05-27 | 29 |
| K802764 | PLASTIC ADHESIVE BANDAGE | KGX | 1980-11-24 | 20 |
| K802139 | SPATULA, CERVICAL CYTOLOGICAL CYTOLOGY | HHT | 1980-10-31 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Dyn-A-Med Products.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Dyn-A-Med Products have?
Dyn-A-Med Products has 5 FDA 510(k) clearances (first 1980, latest 1984), across 5 product codes in 4 review panels.
How long does FDA take to clear Dyn-A-Med Products's 510(k)s?
The median time from FDA receipt to decision across Dyn-A-Med Products's cleared 510(k)s is 47 days.
What devices does Dyn-A-Med Products make?
Its most frequent FDA product codes are DRX (Electrode, Electrocardiograph, 1); FKK (Clamp, Line, 1); HHT (Spatula, Cervical, Cytological, 1).
Has Dyn-A-Med Products had device recalls?
openFDA lists no recalls under a recalling firm name matching Dyn-A-Med Products. Related entities may recall under other names.
Next steps
- See all 5 Dyn-A-Med Products clearances with predicates and recalls
- Run predicate analysis for product code DRX, Dyn-A-Med Products's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.