Dacomed Corp.: FDA clearances and approvals
Dacomed Corp. has 20 FDA 510(k) clearances (first 1981, latest 1995), across 10 product codes in 3 review panels. Median 510(k) review time: 86 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 |
|---|---|---|---|
| FAE | Prosthesis, Penile | 7 | 7 |
| LIL | Monitor, Penile Tumescence | 4 | 4 |
| LKY | Device, External Penile Rigidity | 2 | 2 |
| EWL | Prosthesis, Laryngeal (Taub) | 1 | 1 |
| EXQ | Cystometer, Electrical Recording | 1 | 1 |
| FAT | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology | 1 | 1 |
| FHA | Clamp, Penile | 1 | 1 |
| FTQ | Prosthesis, Penis, Rigid Rod | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 1 | 1 |
Review panels
Most recent Dacomed Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953640 | DUNA II PENILE PROSTHESIS | FAE | 1995-10-27 | 84 |
| K941781 | RIGISCAN PLUS RIGIDITY ASSESSMENT SYSTEM | LIL | 1994-08-25 | 136 |
| K920409 | DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE | LKY | 1992-05-11 | 101 |
| K920420 | DURA II PENILE PROSTHESIS | FAE | 1992-04-16 | 76 |
| K912344 | MODIFIED DURAPHASE(TM) IMPLANTED PENILE PROSTHESIS | FAE | 1991-10-11 | 136 |
| K900774 | DACOMED NEGATIVE PRESSURE ERECTION DEVICE | LKY | 1990-05-04 | 73 |
| K885323 | DACOMED EXTERNAL MALE CONTINENCE DEVICE | FHA | 1989-02-08 | 42 |
| K880391 | DACOMED CYSTOMETER | EXQ | 1988-04-27 | 89 |
| K871653 | DURAPHASE PENILE PROSTHESIS | FAE | 1987-09-18 | 143 |
| K870320 | DACOMED PENILE PROSTHESIS SIZER | JLW | 1987-03-17 | 48 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dacomed 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 Dacomed Corp. have?
Dacomed Corp. has 20 FDA 510(k) clearances (first 1981, latest 1995), across 10 product codes in 3 review panels.
How long does FDA take to clear Dacomed Corp.'s 510(k)s?
The median time from FDA receipt to decision across Dacomed Corp.'s cleared 510(k)s is 86 days.
What devices does Dacomed Corp. make?
Its most frequent FDA product codes are FAE (Prosthesis, Penile, 7); LIL (Monitor, Penile Tumescence, 4); LKY (Device, External Penile Rigidity, 2).
Has Dacomed Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dacomed Corp. Related entities may recall under other names.
Next steps
- See all 20 Dacomed Corp. clearances with predicates and recalls
- Run predicate analysis for product code FAE, Dacomed 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.