Dio-Med Corp.: FDA clearances and approvals
Dio-Med Corp. has 7 FDA 510(k) clearances (first 1981, latest 1994), across 2 product codes in 2 review panels. Median 510(k) review time: 223 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 6 | 6 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
Review panels
Most recent Dio-Med Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933525 | DIOMED 25 25W SURGICAL DIODE LASER | GEX | 1994-03-01 | 223 |
| K931776 | DIOMED 25 25W SURGICAL DIODE LASER | GEX | 1993-10-19 | 193 |
| K931212 | DIOMED 25 25W SURGICAL DIODE LASER | GEX | 1993-09-23 | 197 |
| K914519 | DIOMED 25 SURGICAL DIODE LASER, GYNECOLOGY APPLIC | GEX | 1993-09-16 | 707 |
| K914520 | DIOMED 25 SURGICAL DIODE LASER, UROLOGY APPLICAT | GEX | 1993-01-22 | 470 |
| K914521 | DIOMED 25 SURGICAL DIODE LASER, GEN SURG APPLICAT | GEX | 1993-01-15 | 463 |
| K813267 | DISPOSABLE DIAPHRAGM DOMES | DRS | 1981-12-14 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named Dio-Med Corp..
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 Dio-Med Corp. have?
Dio-Med Corp. has 7 FDA 510(k) clearances (first 1981, latest 1994), across 2 product codes in 2 review panels.
How long does FDA take to clear Dio-Med Corp.'s 510(k)s?
The median time from FDA receipt to decision across Dio-Med Corp.'s cleared 510(k)s is 223 days.
What devices does Dio-Med Corp. make?
Its most frequent FDA product codes are GEX (Powered Laser Surgical Instrument, 6); DRS (Transducer, Blood-Pressure, Extravascular, 1).
Has Dio-Med Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dio-Med Corp. Related entities may recall under other names.
Next steps
- See all 7 Dio-Med Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Dio-Med Corp.'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.